21 CFR Part 900 — Mammography

PART 900—MAMMOGRAPHY Authority: 21 U.S.C. 360i, 360nn, 374(e); 42 U.S.C. 263b. Source: 62 FR 55976, Oct. 28, 1997, unless otherwise noted. Republished and corrected at 62 FR 60614, Nov. 10, 1997. Subpart A—Accreditation § 900.1 Scope. The regulations set forth in this part implement the Mammography Quality Standards Act (MQSA) (42 U.S.C. 263b). Subpart A of this part establishes procedures whereby an entity can apply to become a Food and Drug Administration (FDA)-approved accreditation body to accredit facilities to be eligible to perform screening or diagnostic mammography services. Subpart A further establishes requirements and standards for accreditation bodies to ensure that all mammography facilities under the jurisdiction of the United States are adequately and consistently evaluated for compliance with national quality standards for mammography. Subpart B of this part establishes minimum national quality standards for mammography facilities to ensure safe, reliable, and accurate mammography. The regulations set forth in this part do not apply to facilities of the Department of Veterans Affairs. § 900.2 Definitions. The following definitions apply to subparts A, B, and C of this part: (a) Accreditation body body (b) Action limits action levels (c) Adverse event (1) Poor image quality; (2) Failure to send mammography reports within 30 days to the referring healthcare provider or in a timely manner to the self-referred patient; and (3) Use of personnel that do not meet the applicable requirements of § 900.12(a). (d) Air kerma (e) Breast implant (f) Calendar quarter (g) Category I (h) Certificate (i) Certification (j) Clinical image (k) Consumer e.g., (l) Continuing education unit continuing education credit (m) Contact hour (n) Direct instruction (1) Face-to-face interaction between instructor(s) and student(s), as when the instructor provides a lecture, conducts demonstrations, or reviews student performance; or (2) The administration and correction of student examinations by an instructor(s) with subsequent feedback to the student(s). (o) Direct supervision (1) During joint interpretation of mammograms, the supervising interpreting physician reviews, discusses, and confirms the diagnosis of the physician being supervised and signs the resulting report before it is entered into the patient's records; or (2) During the performance of a mammography examination or survey of the facility's equipment and quality assurance program, the supervisor is present to observe and correct, as needed, the performance of the individual being supervised who is performing the examination or conducting the survey. (p) Established operating level (q) Facility (r) First allowable time (s) FDA (t) Interim regulations (u) Interpreting physician (v) Kerma (w) Laterality (x) Lead interpreting physician (y) Mammogram (z) Mammographic modality (aa) Mammography (1) Radiography of the breast performed during invasive interventions for localization or biopsy procedures; (2) Radiography of the breast performed with an investigational mammography device as part of a scientific study conducted in accordance with FDA's investigational device exemption regulations in part 812 of this chapter; or (3) Computed tomography of the breast. (bb) Mammography equipment evaluation (cc) Mammography medical outcomes audit (dd) Mammography unit units (ee) Mean optical density (ff) Medical physicist (gg) MQSA (hh) Multi-reading (ii) Patient (jj) Phantom (kk) Phantom image (ll) Physical science (mm) Positive mammogram (nn) Provisional certificate (oo) Qualified instructor (pp) Quality control technologist (qq) Radiographic equipment (rr) Radiologic technologist (ss) Serious adverse event (tt) Serious complaint (uu) Standard breast (vv) Survey (ww) Time cycle (xx) Traceable to a national standard (yy) Review physician (zz) Certification agency (aaa) Performance indicators (bbb) Authorization [62 FR 55976, Oct. 28, 1997; 62 FR 60614, Nov. 10, 1997, as amended at 63 FR 56558, Oct. 22, 1998; 64 FR 32407, June 17, 1999; 67 FR 5467, Feb. 6, 2002; 88 FR 15168, Mar. 10, 2023] § 900.3 Application for approval as an accreditation body. (a) Eligibility. (b) Application for initial approval. (2) Following receipt of the request, FDA will provide the applicant with additional information to aid in submission of an application for approval as an accreditation body. (3) The applicant shall furnish to FDA, at the address in § 900.3(b)(1), three copies of an application containing the following information, materials, and supporting documentation: (i) Name, address, and phone number of the applicant and, if the applicant is not a State agency, evidence of nonprofit status (i.e., of fulfilling Internal Revenue Service requirements as a nonprofit organization); (ii) Detailed description of the accreditation standards the applicant will require facilities to meet and a discussion substantiating their equivalence to FDA standards required under § 900.12; (iii) Detailed description of the applicant's accreditation review and decisionmaking process, including: (A) Procedures for performing accreditation and reaccreditation clinical image review in accordance with § 900.4(c), random clinical image reviews in accordance with § 900.4(f), and additional mammography review in accordance with § 900.12(j); (B) Procedures for performing phantom image review; (C) Procedures for assessing mammography equipment evaluations and surveys; (D) Procedures for initiating and performing onsite visits to facilities; (E) Procedures for assessing facility personnel qualifications; (F) Copies of the accreditation application forms, guidelines, instructions, and other materials the applicant will send to facilities during the accreditation process, including an accreditation history form that requires each facility to provide a complete history of prior accreditation activities and a statement that all information and data submitted in the application is true and accurate, and that no material fact has been omitted; (G) Policies and procedures for notifying facilities of deficiencies; (H) Procedures for monitoring corrections of deficiencies by facilities; (I) Policies and procedures for suspending or revoking a facility's accreditation; (J) Policies and procedures that will ensure processing of accreditation applications and renewals within a timeframe approved by FDA and assurances that the body will adhere to such policies and procedures; and (K) A description of the applicant's appeals process for facilities contesting adverse accreditation status decisions. (iv) Education, experience, and training requirements for the applicant's professional staff, including reviewers of clinical or phantom images; (v) Description of the applicant's electronic data management and analysis system with respect to accreditation review and decision processes and the applicant's ability to provide electronic data in a format compatible with FDA data systems; (vi) Resource analysis that demonstrates that the applicant's staffing, funding, and other resources are adequate to perform the required accreditation activities; (vii) Fee schedules with supporting cost data; (viii) Statement of policies and procedures established to avoid conflicts of interest or the appearance of conflicts of interest by the applicant's board members, commissioners, professional personnel (including reviewers of clinical and phantom images), consultants, administrative personnel, and other representatives of the applicant; (ix) Statement of policies and procedures established to protect confidential information the applicant will collect or receive in its role as an accreditation body; (x) Disclosure of any specific brand of imaging system or component, measuring device, software package, or other commercial product used in mammography that the applicant develops, sells, or distributes; (xi) Description of the applicant's consumer complaint mechanism; (xii) Satisfactory assurances that the applicant shall comply with the requirements of § 900.4; and (xiii) Any other information as may be required by FDA. (c) Application for renewal of approval. (1) At least 9 months before the date of expiration of a body's approval, the body shall inform FDA, at the address given in § 900.3(b)(1), of its intent to seek renewal. (2) FDA will notify the applicant of the relevant information, materials, and supporting documentation required under § 900.3(b)(3) that the applicant shall submit as part of the renewal procedure. (3) At least 6 months before the date of expiration of a body's approval, the applicant shall furnish to FDA, at the address in § 900.3(b)(1), three copies of a renewal application containing the information, materials, and supporting documentation requested by FDA in accordance with § 900.3(c)(2). (4) No later than July 28, 1998, any accreditation body approved under the interim regulations published in the Federal Register (5) Any accreditation body that does not plan to renew its approval shall so notify FDA at the address given in paragraph (b)(1) of this section at least 9 months before the expiration of the body's term of approval. (d) Rulings on applications for initial and renewed approval. (2) FDA will notify the applicant of any deficiencies in the application and request that those deficiencies be rectified within a specified time period. If the deficiencies are not rectified to FDA's satisfaction within the specified time period, the application for approval as an accreditation body may be rejected. (3) FDA shall notify the applicant whether the application has been approved or denied. That notification shall list any conditions associated with approval or state the bases for any denial. (4) The review of any application may include a meeting between FDA and representatives of the applicant at a time and location mutually acceptable to FDA and the applicant. (5) FDA will advise the applicant of the circumstances under which a denied application may be resubmitted. (6) If FDA does not reach a final decision on a renewal application in accordance with this paragraph before the expiration of an accreditation body's current term of approval, the approval will be deemed extended until the agency reaches a final decision on the application, unless an accreditation body does not rectify deficiencies in the application within the specified time period, as required in paragraph (d)(2) of this section. (e) Relinquishment of authority. (f) Transfer of records. (1) Transfer facility records and other related information as required by FDA to a location and according to a schedule approved by FDA. (2) Notify, in a manner and time period approved by FDA, all facilities accredited or seeking accreditation by the body that the body will no longer have accreditation authority. (g) Scope of authority. [62 FR 55976, Oct. 28, 1997; 62 FR 60614, Nov. 10, 1997, as amended at 83 FR 13864, Apr. 2, 2018; 85 FR 18443, Apr. 2, 2020] § 900.4 Standards for accreditation bodies. (a) Code of conduct and general responsibilities. (1)(i) When an accreditation body receives or discovers information that suggests inadequate image quality, or upon request by FDA, the accreditation body shall review a facility's clinical images or other aspects of a facility's practice to assist FDA in determining whether or not the facility's practice poses a serious risk to human health. Such reviews are in addition to the evaluation an accreditation body performs as part of the initial accreditation or renewal process for facilities. (ii) If review by the accreditation body demonstrates that a problem does exist with respect to image quality or other aspects of a facility's compliance with quality standards, or upon request by FDA, the accreditation body shall require or monitor corrective actions, or suspend or revoke accreditation of the facility. (2) The accreditation body shall inform FDA as soon as possible but in no case longer than 2 business days after becoming aware of equipment or practices that pose a serious risk to human health. (3) The accreditation body shall establish and administer a quality assurance (QA) program that has been approved by FDA in accordance with § 900.3(d) or paragraph (a)(8) of this section. Such quality assurance program shall: (i) Include requirements for clinical image review and phantom image review; (ii) Ensure that clinical and phantom images are evaluated consistently and accurately; and (iii) Specify the methods and frequency of training and evaluation for clinical and phantom image reviewers, and the bases and procedures for removal of such reviewers. (4) The accreditation body shall establish measures that FDA has approved in accordance with § 900.3(d) or paragraph (a)(8) of this section to reduce the possibility of conflict of interest or facility bias on the part of individuals acting on the body's behalf. Such individuals who review clinical or phantom images under the provisions of paragraphs (c) and (d) of this section or who visit facilities under the provisions of paragraph (f) of this section shall not review clinical or phantom images from or visit a facility with which such individuals maintain a relationship, or when it would otherwise be a conflict of interest for them to do so, or when they have a bias in favor of or against the facility. (5) The accreditation body may require specific equipment performance or design characteristics that FDA has approved. However, no accreditation body shall require, either explicitly or implicitly, the use of any specific brand of imaging system or component, measuring device, software package, or other commercial product as a condition for accreditation by the body, unless FDA determines that it is in the best interest of public health to do so. (i) Any representation, actual or implied, either orally, in sales literature, or in any other form of representation, that the purchase or use of a particular product brand is required in order for any facility to be accredited or certified under § 900.11(b), is prohibited, unless FDA approves such representation. (ii) Unless FDA has approved the exclusive use and promotion of a particular commercial product in accordance with this section, all products produced, distributed, or sold by an accreditation body or an organization that has a financial or other relationship with the accreditation body that may be a conflict of interest or have the appearance of a conflict of interest with the body's accreditation functions, shall bear a disclaimer stating that the purchase or use of such products is not required for accreditation or certification of any facility under § 900.11(b). Any representations about such products shall include a similar disclaimer. (6)(i) When an accreditation body denies accreditation to a facility, the accreditation body shall notify the facility in writing and explain the bases for its decision. The notification shall also describe the appeals process available from the accreditation body for the facility to contest the decision. (ii) If a facility has failed to become accredited after three consecutive attempts, no accreditation body shall accept an application for accreditation from the facility for a period of 1 year from the date of the most recent accreditation failure. (7) No accreditation body may establish requirements that preclude facilities from being accredited under § 900.11(b) by any other accreditation body, or require accreditation by itself under MQSA if another accreditation body is available to a facility. (8) The accreditation body shall obtain FDA authorization for any changes it proposes to make in any standards that FDA has previously accepted under § 900.3(d). (9) An accreditation body shall establish procedures to protect confidential information it collects or receives in its role as an accreditation body. (i) Nonpublic information collected from facilities for the purpose of carrying out accreditation body responsibilities shall not be used for any other purpose or disclosed, other than to FDA or its duly designated representatives, including State agencies, without the consent of the facility; (ii) Nonpublic information that FDA or its duly designated representatives, including State agencies, share with the accreditation body concerning a facility that is accredited or undergoing accreditation by that body shall not be further disclosed except with the written permission of FDA. (b) Monitoring facility compliance with quality standards. (2) The accreditation body shall notify a facility regarding equipment, personnel, and other aspects of the facility's practice that do not meet such standards and advise the facility that such equipment, personnel, or other aspects of the practice should not be used by the facility for activities within the scope of part 900. (3) The accreditation body shall specify the actions that facilities shall take to correct deficiencies in equipment, personnel, and other aspects of the practice to ensure facility compliance with applicable standards. (4) If deficiencies cannot be corrected to ensure compliance with standards or if a facility is unwilling to take corrective actions, the accreditation body shall immediately so notify FDA, and shall suspend or revoke the facility's accreditation in accordance with the policies and procedures described under § 900.3(b)(3)(iii)(I). (c) Clinical image review for accreditation and reaccreditation Frequency of review. (2) Requirements for clinical image attributes. (i) Positioning. (ii) Compression. (iii) Exposure level. (iv) Contrast. (v) Sharpness. (vi) Noise. (vii) Artifacts. (viii) Examination identification. (A) Name of the patient and an additional patient identifier. (B) Date of examination. (C) View and laterality. (D) Facility name and location. (E) Technologist identification. (F) Cassette/screen identification. (G) Mammography unit identification, if there is more than one unit in the facility. (3) Scoring of clinical images. (i) The accreditation body shall establish and employ criteria for acceptable and nonacceptable results for each of the 8 attributes as well as an overall pass-fail system for clinical image review that has been approved by FDA in accordance with § 900.3(d) or paragraph (a)(8) of this section. (ii) All clinical images submitted by a facility to the accreditation body shall be reviewed independently by two or more review physicians. (4) Selection of clinical images for review. (i) The facility shall submit craniocaudal (CC) and mediolateral oblique (MLO) views from two mammographic examinations that the facility produced during a time period specified by the accreditation body; (ii) Clinical images submitted from one such mammographic examination for each unit shall be of dense breasts (predominance of glandular tissue) and the other shall be of fat-replaced breasts (predominance of adipose tissue); (iii) All clinical images submitted shall be images that the facility's interpreting physician(s) interpreted as negative or benign. (iv) If the facility has no clinical images meeting the requirements in paragraphs (c)(4)(i) through (c)(4)(iii) of this section, it shall so notify the accreditation body, which shall specify alternative clinical image selection methods that do not compromise care of the patient. (5) Review physicians. (i) Meet the interpreting physician requirements specified in § 900.12(a)(1) and meet such additional requirements as have been established by the accreditation body and approved by FDA; (ii) Are trained and evaluated in the clinical image review process, for the types of clinical images to be evaluated by a review physician, by the accreditation body before designation as review physicians and periodically thereafter; and (iii) Clearly document their findings and reasons for assigning a particular score to any clinical image and provide information to the facility for use in improving the attributes for which significant deficiencies were identified. (6) Image management. (i) If the clinical images are needed earlier by the facility for clinical purposes, the accreditation body shall cooperate with the facility to accommodate such needs. (ii) If a review physician identifies a suspicious abnormality on an image submitted for clinical image review, the accreditation body shall ensure that this information is provided to the facility and that the clinical images are returned to the facility. Both shall occur no later than 10-business days after identification of the suspected abnormality. (7) Notification of unsatisfactory image quality. (d) Phantom image review for accreditation and reaccreditation Frequency of review. (2) Requirements for the phantom used. (3) Scoring phantom images. (4) Phantom images selected for review. (5) Phantom image reviewers. (i) Meet the requirements specified in § 900.12(a)(3) or alternative requirements established by the accreditation body and approved by FDA in accordance with § 900.3 or paragraph (a)(8) of this section; (ii) Are trained and evaluated in the phantom image review process, for the types of phantom images to be evaluated by a phantom image reviewer, by the accreditation body before designation as phantom image reviewers and periodically thereafter; and (iii) Clearly document their findings and reasons for assigning a particular score to any phantom image and provide information to the facility for use in improving its phantom image quality with regard to the significant deficiencies identified. (6) Image management. (7) Notification measures for unsatisfactory image quality. (e) Reports of mammography equipment evaluation, surveys, and quality control. (1) The accreditation body shall require every facility applying for accreditation to submit: (i) With its initial accreditation application, a mammography equipment evaluation that was performed by a medical physicist no earlier than 6 months before the date of application for accreditation by the facility. Such evaluation shall demonstrate compliance of the facility's equipment with the requirements in § 900.12(e). (ii) Prior to accreditation, a survey that was performed no earlier than 6 months before the date of application for accreditation by the facility. Such survey shall assess the facility's compliance with the facility standards referenced in paragraph (b) of this section. (2) The accreditation body shall require that all facilities undergo an annual survey to ensure continued compliance with the standards referenced in paragraph (b) of this section and to provide continued oversight of facilities' quality control programs as they relate to such standards. The accreditation body shall require for all facilities that: (i) Such surveys be conducted annually; (ii) Facilities take reasonable steps to ensure that they receive reports of such surveys within 30 days of survey completion; and (iii) Facilities submit the results of such surveys and any other information that the body may require to the body at least annually. (3) The accreditation body shall review and analyze the information required in this section and use it to identify necessary corrective measures for facilities and to determine whether facilities should remain accredited by the body. (f) Accreditation body onsite visits and random clinical image reviews. (1) Onsite visits Sample size. (A) At least 50 percent of the facilities visited shall be selected randomly. (B) Other facilities visited shall be selected based on problems identified through State or FDA inspections, serious complaints received from consumers or others, a previous history of noncompliance, or any other information in the possession of the accreditation body, inspectors, or FDA. (C) Before, during, or after any facility visit, the accreditation body may require that the facility submit to the body for review clinical images, phantom images, or any other information relevant to applicable standards in this subpart and in subpart B of this part. (ii) Visit plan. (A) Assessment of overall clinical image QA activities of the facility; (B) Review of facility documentation to determine if appropriate mammography reports are sent to patients and providers as required; (C) Selection of a sample of clinical images for clinical image review by the accreditation body. Clinical images shall be selected in a manner specified by the accreditation body and approved by FDA that does not compromise care of the patient as a result of the absence of the selected images from the facility; (D) Verification that the facility has a medical audit system in place and is correlating films and pathology reports for positive cases; (E) Verification that personnel specified by the facility are the ones actually performing designated personnel functions; (F) Verification that equipment specified by the facility is the equipment that is actually being used to perform designated equipment functions; (G) Verification that a consumer complaint mechanism is in place and that the facility is following its procedures; and (H) Review of all factors related to previously identified concerns or concerns identified during that visit. (2) Clinical image review for random sample of facilities Sample size. (ii) Random clinical image review. (iii) Accreditation bodies should not schedule random clinical image reviews at facilities that have received notification of the need to begin the accreditation renewal process or that have completed the accreditation renewal process within the previous 6 months. (iv) Selection of the random sample of clinical images for clinical image review by the accreditation body. (g) Consumer complaint mechanism. (1) Provide a mechanism for all facilities it accredits to file serious unresolved complaints with the accreditation body; (2) Maintain a record of every serious unresolved complaint received by the body on all facilities it accredits for a period of at least 3 years from the date of receipt of each such complaint; (h) Reporting and recordkeeping. (1) Collect and submit to FDA the information required by 42 U.S.C. 263b(d) for each facility when the facility is initially accredited and at least annually when updated, in a manner and at a time specified by FDA. (2) Accept applications containing the information required in 42 U.S.C. 263b(c)(2) for provisional certificates and in § 900.11(b)(3) for extension of provisional certificates, on behalf of FDA, and notify FDA of the receipt of such information; (3) Submit to FDA the name, identifying information, and other information relevant to 42 U.S.C. 263b and specified by FDA for any facility for which the accreditation body denies, suspends, or revokes accreditation, and the reason(s) for such action; (4) Submit to FDA an annual report summarizing all serious complaints received during the previous calendar year, their resolution status, and any actions taken in response to them; (5) Provide to FDA other information relevant to 42 U.S.C. 263b and required by FDA about any facility accredited or undergoing accreditation by the body. (i) Fees. (1) The accreditation body shall make public its fee structure, including those factors, if any, contributing to variations in fees for different facilities. (2) At FDA's request, accreditation bodies shall provide financial records or other material to assist FDA in assessing the reasonableness of accreditation body fees. Such material shall be provided to FDA in a manner and time period specified by the agency. [62 FR 55976, Oct. 28, 1997; 62 FR 60614, Nov. 10, 1997, as amended at 64 FR 32407, June 17, 1999; 88 FR 15168, Mar. 10, 2023] § 900.5 Evaluation. FDA shall evaluate annually the performance of each accreditation body. Such evaluation shall include an assessment of the reports of FDA or State inspections of facilities accredited by the body as well as any additional information deemed relevant by FDA that has been provided by the accreditation body or other sources or has been required by FDA as part of its oversight initiatives. The evaluation shall include a determination of whether there are major deficiencies in the accreditation body's performance that, if not corrected, would warrant withdrawal of the approval of the accreditation body under the provisions of § 900.6. § 900.6 Withdrawal of approval. If FDA determines, through the evaluation activities of § 900.5, or through other means, that an accreditation body is not in substantial compliance with this subpart, FDA may initiate the following actions: (a) Major deficiencies. (1) FDA shall notify the accreditation body of the agency's action and the grounds on which the approval was withdrawn. (2) An accreditation body that has lost its approval shall notify facilities accredited or seeking accreditation by it that its approval has been withdrawn. Such notification shall be made within a time period and in a manner approved by FDA. (b) Minor deficiencies. (1) If FDA places an accreditation body on probationary status, the body shall notify all facilities accredited or seeking accreditation by it of its probationary status within a time period and in a manner approved by FDA. (2) Probationary status shall remain in effect until such time as the body can demonstrate to the satisfaction of FDA that it has successfully implemented or is implementing the corrective action plan within the established schedule, and that the corrective actions have substantially eliminated all identified problems. (3) If FDA determines that an accreditation body that has been placed on probationary status is not implementing corrective actions satisfactorily or within the established schedule, FDA may withdraw approval of the accreditation body. The accreditation body shall notify all facilities accredited or seeking accreditation by it of its loss of FDA approval, within a time period and in a manner approved by FDA. (c) Reapplication by accreditation bodies that have had their approval withdrawn. (2) If FDA determines that the new application demonstrates that the body satisfactorily has addressed the causes of its previous unacceptable performance, FDA may reinstate approval of the accreditation body. (3) FDA may request additional information or establish additional conditions that must be met by a former accreditation body before FDA approves the reapplication. (4) FDA may refuse to accept an application from a former accreditation body whose approval was withdrawn because of fraud or willful disregard of public health. § 900.7 Hearings. (a) Opportunities to challenge final adverse actions taken by FDA regarding approval or reapproval of accreditation bodies, withdrawal of approval of accreditation bodies, or rejection of a proposed fee for accreditation shall be communicated through notices of opportunity for informal hearings in accordance with part 16 of this chapter. (b) A facility that has been denied accreditation is entitled to an appeals process from the accreditation body. The appeals process shall be specified in writing by the accreditation body and shall have been approved by FDA in accordance with § 900.3(d) or § 900.4(a)(8). (c) A facility that cannot achieve satisfactory resolution of an adverse accreditation decision through the accreditation body's appeals process may appeal to FDA for reconsideration in accordance with § 900.15. §§ 900.8-900.9 [Reserved] Subpart B—Quality Standards and Certification § 900.10 Applicability. The provisions of subpart B are applicable to all facilities under the regulatory jurisdiction of the United States that provide mammography services, with the exception of the Department of Veterans Affairs. § 900.11 Requirements for certification. (a) General. (b) Application Certificates. (ii) Following the agency's receipt of the accreditation body's decision to accredit a facility, or an equivalent decision by another entity designated by FDA, the agency may issue a certificate to the facility, or renew an existing certificate, if the agency determines that the facility has satisfied the requirements for certification or recertification. (2) Provisional certificates. (ii) Following the agency's receipt of the accreditation body's decision that a facility has submitted the required information, FDA may issue a provisional certificate to a facility upon determination that the facility has satisfied the requirements of § 900.11(b)(2)(i). A provisional certificate shall be effective for up to 6 months from the date of issuance. A provisional certificate cannot be renewed, but a facility may apply for a 90-day extension of the provisional certificate. (3) Extension of provisional certificate. (ii) The accreditation body shall forward the request, with its recommendation, to FDA within 2 business days after receipt. (iii) FDA may issue a 90-day extension for a provisional certificate upon determination that the extension meets the criteria set forth in 42 U.S.C. 263b(c)(2). (iv) There can be no renewal of a provisional certificate beyond the 90-day extension. (c) Reinstatement policy. (1) Unless prohibited from reinstatement under § 900.11(c)(4), a facility applying for reinstatement shall: (i) Contact an FDA-approved accreditation body or other entity designated by FDA to determine the requirements for reapplication for accreditation; (ii) Fully document its history as a previously provisionally certified or certified mammography facility, including the following information: (A) Name and address of the facility under which it was previously provisionally certified or certified; (B) Name of previous owner/lessor; (C) FDA facility identification number assigned to the facility under its previous certification; and (D) Expiration date of the most recent FDA provisional certificate or certificate; and (iii) Justify application for reinstatement of accreditation by submitting to the accreditation body or other entity designated by FDA, a corrective action plan that details how the facility has corrected deficiencies that contributed to the lapse of, denial of renewal, or revocation of its certificate. (2) FDA may issue a provisional certificate to the facility if: (i) The accreditation body or other entity designated by FDA notifies the agency that the facility has adequately corrected, or is in the process of correcting, pertinent deficiencies; and (ii) FDA determines that the facility has taken sufficient corrective action since the lapse of, denial of renewal, or revocation of its previous certificate. (3) After receiving the provisional certificate, the facility may lawfully resume performing mammography services while completing the requirements for certification. (4) If a facility's certificate was revoked on the basis of an act described in 42 U.S.C. 263b(i)(1), as implemented by § 900.14(a), no person who owned or operated that facility at the time the act occurred may own or operate a mammography facility within 2 years of the date of revocation. [62 FR 55976, Oct. 28, 1997; 62 FR 60614, Nov. 10, 1997, as amended at 83 FR 13864, Apr. 2, 2018; 88 FR 15168, Mar. 10, 2023] § 900.12 Quality standards. (a) Personnel. (1) Interpreting physicians. (i) Initial qualifications. (A) Be licensed to practice medicine in a State; (B)( 1 ( 2 (C) Have a minimum of 60 hours of documented medical education in mammography, which shall include: Instruction in the interpretation of mammograms and education in basic breast anatomy, pathology, physiology, technical aspects of mammography, and quality assurance and quality control in mammography. All 60 of these hours shall be category I and at least 15 of the category I hours shall have been acquired within the 3 years immediately prior to the date that the physician qualifies as an interpreting physician. Hours spent in residency specifically devoted to mammography will be considered as equivalent to Category I continuing medical education credits and will be accepted if documented in writing by the appropriate representative of the training institution; and (D) Unless the exemption in paragraph (a)(1)(iii)(B) of this section applies, have interpreted or multi-read at least 240 mammographic examinations within the 6-month period immediately prior to the date that the physician qualifies as an interpreting physician. This interpretation or multi-reading shall be under the direct supervision of an interpreting physician. (ii) Continuing experience and education. (A) Following the second anniversary date of the end of the calendar quarter in which the requirements of paragraph (a)(1)(i) of this section were completed, the interpreting physician shall have interpreted or multi-read at least 960 mammographic examinations during the 24 months immediately preceding the date of the facility's annual MQSA inspection or the last day of the calendar quarter preceding the inspection or any date in-between the two. The facility will choose one of these dates to determine the 24-month period. (B) Following the third anniversary date of the end of the calendar quarter in which the requirements of paragraph (a)(1)(i) of this section were completed, the interpreting physician shall have taught or completed at least 15 category I continuing medical education units in mammography during the 36 months immediately preceding the date of the facility's annual MQSA inspection or the last day of the calendar quarter preceding the inspection or any date in between the two. The facility will choose one of these dates to determine the 36-month period. This training shall include at least six category I continuing medical education credits in each mammographic modality used by the interpreting physician in his or her practice; and (C) Before an interpreting physician may begin independently interpreting mammograms produced by a new mammographic modality, that is, a mammographic modality in which the physician has not previously been trained, the interpreting physician shall have at least 8 hours of training in the new mammographic modality. (D) Units earned through teaching a specific course can be counted only once towards the 15 required by paragraph (a)(1)(ii)(B) of this section, even if the course is taught multiple times during the previous 36 months. (iii) Exemptions. (B) Physicians who have interpreted or multi-read at least 240 mammographic examinations under the direct supervision of an interpreting physician in any 6-month period during the last 2 years of a diagnostic radiology residency and who become appropriately board certified at the first allowable time, as defined by an eligible certifying body, are otherwise exempt from paragraph (a)(1)(i)(D) of this section. (iv) Reestablishing qualifications. (A) Interpreting physicians who fail to meet the continuing experience requirements of paragraph (a)(1)(ii)(A) of this section shall: ( 1 ( 2 ( 3 1 2 (B) Interpreting physicians who fail to meet the continuing education requirements of paragraph (a)(1)(ii)(B) of this section shall obtain a sufficient number of additional category I continuing medical education credits in mammography to bring their total up to the required 15 credits in the previous 36 months before resuming independent interpretation. (2) Radiologic technologists. (i) General requirements. (B) Have general certification from one of the bodies determined by FDA to have procedures and requirements adequate to ensure that radiologic technologists certified by the body are competent to perform radiologic examinations; and (ii) Mammography requirements. (A) Training in breast anatomy and physiology, positioning and compression, quality assurance/quality control techniques, imaging of patients with breast implants; (B) The performance of a minimum of 25 examinations under the direct supervision of an individual qualified under paragraph (a)(2) of this section; and (C) At least 8 hours of training in each mammography modality to be used by the technologist in performing mammography exams; and (iii) Continuing education requirements. (B) Units earned through teaching a specific course can be counted only once towards the 15 required in paragraph (a)(2)(iii)(A) of this section, even if the course is taught multiple times during the previous 36 months. (C) At least six of the continuing education units required in paragraph (a)(2)(iii)(A) of this section shall be related to each mammographic modality used by the technologist. (D) Requalification. (E) Before a radiologic technologist may begin independently performing mammographic examinations using a mammographic modality other than one of those for which the technologist received training under paragraph (a)(2)(ii)(C) of this section, the technologist shall have at least 8 hours of continuing education units in the new modality. (iv) Continuing experience requirements. (B) Requalification. (3) Medical physicists. (i) Initial qualifications. (B)( 1 ( 2 ( 3 (ii) Alternative initial qualifications. (B) Prior to the April 28, 1999, have: ( 1 ( 2 ( 3 (iii) Continuing qualifications. (B) Continuing experience. (C) Before a medical physicist may begin independently performing mammographic surveys of a new mammographic modality, that is, a mammographic modality other than one for which the physicist received training to qualify under paragraph (a)(3)(i) or (a)(3)(ii) of this section, the physicist must receive at least 8 hours of training in surveying units of the new mammographic modality. (iv) Reestablishing qualifications. (A) Medical physicists who fail to meet the continuing educational requirements of paragraph (a)(3)(iii)(A) of this section shall obtain a sufficient number of continuing education units to bring their total units up to the required 15 in the previous 3 years. (B) Medical physicists who fail to meet the continuing experience requirement of paragraph (a)(3)(iii)(B) of this section shall complete a sufficient number of surveys under the direct supervision of a medical physicist who meets the qualifications of paragraphs (a)(3)(i) and (a)(3)(iii) of this section to bring their total surveys up to the required two facilities and six units in the previous 24 months. No more than one survey of a specific unit within a period of 60 days can be counted towards the total mammography unit survey requirement. (4) Retention of personnel records. (b) Equipment. (1) Prohibited equipment. (2) General. (i) All devices used in mammography must have met the applicable FDA premarket authorization requirements for medical devices of that type with that intended use. (ii) A mammography unit that is converted from one mammographic modality to another is considered a new unit at the facility under this part and must, prior to clinical use, undergo a mammography equipment evaluation demonstrating compliance with applicable requirements. The facility must also follow its accreditation body's procedures for applying for accreditation of that unit. (3) Motion of tube-image receptor assembly. (ii) The mechanism ensuring compliance with paragraph (b)(3)(i) of this section shall not fail in the event of power interruption. (4) Image receptor sizes. (ii) Systems using screen-film image receptors shall be equipped with moving grids matched to all image receptor sizes provided. (iii) Systems used for magnification procedures shall be capable of operation with the grid removed from between the source and image receptor. (5) Light fields. (6) Magnification. (ii) Systems used for magnification procedures shall provide, at a minimum, at least one magnification value within the range of 1.4 to 2.0. (7) Focal spot selection. (ii) When more than one target material is provided, the system shall indicate, prior to exposure, the preselected target material. (iii) When the target material and/or focal spot is selected by a system algorithm that is based on the exposure or on a test exposure, the system shall display, after the exposure, the target material and/or focal spot actually used during the exposure. (8) Compression. (i) Application of compression. (A) An initial power-driven compression activated by hands-free controls operable from both sides of the patient; and (B) Fine adjustment compression controls operable from both sides of the patient. (ii) Compression paddle. (B) Except as provided in paragraph (b)(8)(ii)(C) of this section, the compression paddle shall be flat and parallel to the breast support table and shall not deflect from parallel by more than 1.0 cm at any point on the surface of the compression paddle when compression is applied. (C) Equipment intended by the manufacturer's design to not be flat and parallel to the breast support table during compression shall meet the manufacturer's design specifications and maintenance requirements. (D) The chest wall edge of the compression paddle shall be straight and parallel to the edge of the image receptor. (E) The chest wall edge may be bent upward to allow for patient comfort but shall not appear on the image. (9) Technique factor selection and display. (ii) The technique factors (peak tube potential in kilovolt (kV) and either tube current in mA and exposure time in seconds or the product of tube current and exposure time in mAs) to be used during an exposure shall be indicated before the exposure begins, except when automatic exposure controls (AEC) are used, in which case the technique factors that are set prior to the exposure shall be indicated. (iii) Following AEC mode use, the system shall indicate the actual kilovoltage peak (kVp) and mAs used during the exposure. The mAs may be displayed as mA and time. (10) Automatic exposure control. (ii) The positioning or selection of the detector shall permit flexibility in the placement of the detector under the target tissue. (A) The size and available positions of the detector shall be clearly indicated at the X-ray input surface of the breast compression paddle. (B) The selected position of the detector shall be clearly indicated. (iii) The system shall provide means for the operator to vary the selected optical density from the normal (zero) setting. (11) Film. (12) Intensifying screens. (13) Film processing solutions. (14) Lighting. (15) Film masking devices. (16) Equipment—other modalities. (c) Medical records and mammography reports Contents and terminology. (i) The name of the patient and an additional patient identifier; (ii) Date of examination, facility name, and location. At a minimum, the location shall include the city, State, ZIP code, and telephone number of the facility; (iii) The name of the interpreting physician who interpreted the mammogram; (iv) Overall final assessment of findings, classified in one of the following categories (the assessment statement is only the word or phrase within the quotation marks): (A) “Negative.” Nothing to comment upon (if the interpreting physician is aware of clinical findings or symptoms, despite the negative assessment, these shall be documented and addressed); (B) “Benign.” Also a normal result, with benign findings present, but no evidence of malignancy (if the interpreting physician is aware of clinical findings or symptoms, despite the benign assessment, these shall be documented and addressed); (C) “Probably Benign.” Finding(s) has a high probability of being benign; (D) “Suspicious.” Finding(s) without all the characteristic morphology of breast cancer but indicating a definite probability of being malignant; (E) “Highly Suggestive of Malignancy.” Finding(s) has a high probability of being malignant; (F) “Known Biopsy-Proven Malignancy.” Reserved for known malignancies being mammographically evaluated for definitive therapy; and (G) “Post-Procedure Mammogram for Marker Placement.” Reserved for a post-procedure mammogram used to confirm the deployment and position of a breast tissue marker. (v) In cases where no final assessment category can be assigned due to incomplete work-up, one of the following classification statements shall be assigned as an assessment and reasons why no final assessment can be made shall be stated by the interpreting physician. (A) “Incomplete: Need additional imaging evaluation.” Reserved for examinations where additional imaging needs to be performed before an assessment category identified in paragraphs (c)(1)(iv)(A) through (G) of this section can be given; or (B) “Incomplete: Need prior mammograms for comparison.” Reserved for examinations where comparison with prior mammograms should be performed before an assessment category identified in paragraphs (c)(1)(iv)(A) through (G) of this section can be given. If this assessment category is used, a followup report with an assessment category identified in paragraphs (c)(1)(iv)(A) through (E) of this section must be issued within 30 calendar days of the initial report whether or not comparison views can be obtained. (vi) Overall assessment of breast density, classified in one of the following categories: (A) “The breasts are almost entirely fatty.” (B) “There are scattered areas of fibroglandular density.” (C) “The breasts are heterogeneously dense, which may obscure small masses.” (D) “The breasts are extremely dense, which lowers the sensitivity of mammography.” (vii) Recommendations made to the healthcare provider about what additional actions, if any, should be taken. All clinical questions raised by the referring healthcare provider shall be addressed in the report to the extent possible, even if the assessment is negative or benign. (2) Communication of mammography results to the patients. (i) Patients who do not name a healthcare provider to receive the mammography report shall be sent the report described in paragraph (c)(1) of this section within 30 days, in addition to the written notification of results in lay terms. If the assessment of the mammography report is “Suspicious” or “Highly Suggestive of Malignancy,” the facility shall send this report to the patient within 7 calendar days of the final interpretation of the mammograms. (ii) Each facility that accepts patients who do not have a healthcare provider shall maintain a system for referring such patients to a healthcare provider when clinically indicated, which shall include when such patients' mammogram assessment is either probably benign, suspicious, or highly suggestive of malignancy. (iii) If the mammography report identifies the patient's breast density as “The breasts are almost entirely fatty” or “There are scattered areas of fibroglandular density,” the lay summary shall include the statement “Breast tissue can be either dense or not dense. Dense tissue makes it harder to find breast cancer on a mammogram and also raises the risk of developing breast cancer. Your breast tissue is not dense. Talk to your healthcare provider about breast density, risks for breast cancer, and your individual situation.” (iv) If the mammography report identifies the breast density as “The breasts are heterogeneously dense, which may obscure small masses” or “The breasts are extremely dense, which lowers the sensitivity of mammography,” the lay summary shall include the statement “Breast tissue can be either dense or not dense. Dense tissue makes it harder to find breast cancer on a mammogram and also raises the risk of developing breast cancer. Your breast tissue is dense. In some people with dense tissue, other imaging tests in addition to a mammogram may help find cancers. Talk to your healthcare provider about breast density, risks for breast cancer, and your individual situation.” (3) Communication of mammography results to health care providers. (i) Provide a written report of the mammography examination, including the items listed in paragraph (c)(1) of this section, to that health care provider as soon as possible, but no later than 30 days from the date of the mammography examination; and (ii) If the assessment is “Suspicious” or “Highly Suggestive of Malignancy,” the facility shall provide a written report of the mammographic examination, including the items listed in paragraph (c)(1) of this section, to the referring healthcare provider, or if the referring healthcare provider is unavailable, to a responsible designee of the referring healthcare provider within 7 calendar days of the final interpretation of the mammograms. (4) Recordkeeping. (i) Shall (except as provided in paragraph (c)(4)(ii) of this section) maintain the original mammograms and mammography reports in a permanent medical record of the patient for the longest of the following: a period of not less than 5 years, a period of not less than 10 years if no additional mammograms of the patient are performed at the facility, or a period, if any, mandated by State or local law. Facilities shall implement policies and procedures to minimize the possibility of loss of these records. The original mammograms must be retained in retrievable form in the mammographic modality in which they were produced. They cannot be produced by copying or digitizing hardcopy originals. (ii) Shall upon request by, or on behalf of, the patient, permanently or temporarily transfer the original mammograms and copies of the patient's reports to a medical institution, a physician or healthcare provider of the patient, or to the patient directly during the time specified in paragraph (c)(4)(i) of this section. Transfer of the mammograms and mammography reports must take place within 15 calendar days of the facility receiving such request. The transferred mammograms must be in the mammographic modality in which they were produced, and cannot be produced by copying or digitizing hardcopy originals. For digital mammograms or digital breast tomosynthesis, if the examination is being transferred for final interpretation purposes, the facility must be able to provide the recipient with original digital images electronically; (iii) Shall upon request by, or on behalf of, the patient, provide copies of mammograms and copies of mammogram reports to a medical institution, a physician or healthcare provider of the patient, or to the patient directly during the time specified in paragraph (c)(4)(i) of this section. Release of the copies must take place within 15 calendar days of the facility receiving such request. For digital mammograms or digital breast tomosynthesis, if the copies are being released for final interpretation purposes, the facility must be able to provide the recipient with digital images electronically; (iv) Any fee charged to the patients for providing the services in paragraphs (c)(4)(ii) or (iii) of this section shall not exceed the documented costs associated with this service; and (v) Before a facility closes or ceases to provide mammography services, it must make arrangements for access by patients and healthcare providers to their mammographic records. This access may be provided by the permanent transfer of mammographic records to the patient or the patient's healthcare provider or the transfer of the mammographic records to a facility or other entity that will provide access to patients and healthcare providers. Access to the records must be provided by such other facility or entity for the remainder of the time periods specified in paragraph (c)(4)(i) of this section. If a facility ceases to perform mammography but continues to operate as a medical entity, and is able to satisfy the recordkeeping requirements of paragraphs (c)(4)(i) through (iv) of this section, it may choose to continue to retain the medical records rather than transfer them to another facility, unless such a transfer is requested by, or on behalf of, the patient. The facility must notify its accreditation body and certification agency in writing of the arrangements it has made and must make reasonable efforts to notify all affected patients. (5) Mammographic image identification. (i) Name of patient and an additional patient identifier. (ii) Date of examination. (iii) View and laterality. (iv) Facility name and location. (v) Technologist identification. (vi) Cassette/screen identification. (vii) Mammography unit identification, if there is more than one unit in the facility. (d) Quality assurance—general. (1) Responsible individuals. (i) Lead interpreting physician. (ii) Interpreting physicians. (A) Follow the facility procedures for corrective action when the images they are asked to interpret are of poor quality, and (B) Participate in the facility's medical outcomes audit program. (iii) Medical physicist. (iv) Quality control technologist. (2) Quality assurance records. (e) Quality assurance—equipment Daily quality control tests. (i) The base plus fog density shall be within + 0.03 of the established operating level. (ii) The mid-density shall be within ±0.15 of the established operating level. (iii) The density difference shall be within ±0.15 of the established operating level. (2) Weekly quality control tests. (i) The optical density of the film at the center of an image of a standard FDA-accepted phantom shall be at least 1.20 when exposed under a typical clinical condition. (ii) The optical density of the film at the center of the phantom image shall not change by more than ±0.20 from the established operating level. (iii) The phantom image shall achieve at least the minimum score established by the accreditation body and accepted by FDA in accordance with § 900.3(d) or § 900.4(a)(8). (iv) The density difference between the background of the phantom and an added test object, used to assess image contrast, shall be measured and shall not vary by more than ±0.05 from the established operating level. (3) Quarterly quality control tests. (i) Fixer retention in film. (ii) Repeat analysis. (4) Semiannual quality control tests. (i) Darkroom fog. (ii) Screen-film contact. (iii) Compression device performance. (B) Effective October 28, 2002, the maximum compression force for the initial power drive shall be between 111 newtons (25 pounds) and 200 newtons (45 pounds). (5) Annual quality control tests. (i) Automatic exposure control performance. (B) After October 28, 2002, the AEC shall be capable of maintaining film optical density (OD) within ±0.15 of the mean optical density when thickness of a homogeneous material is varied over a range of 2 to 6 cm and the kVp is varied appropriately for such thicknesses over the kVp range used clinically in the facility. (C) The optical density of the film in the center of the phantom image shall not be less than 1.20. (ii) Kilovoltage peak (kVp) accuracy and reproducibility. ( 1 ( 2 ( 3 (B) At the most commonly used clinical settings of kVp, the coefficient of variation of reproducibility of the kVp shall be equal to or less than 0.02. (iii) Focal spot condition. (A) System resolution. 1 ( 2 ( 3 ( 4 ( 5 (B) Focal spot dimensions. Table 1 Focal Spot Tolerance Limit Nominal Focal Spot Size (mm) Maximum Measured Dimensions Width(mm) Length(mm) 0.10 0.15 0.15 0.15 0.23 0.23 0.20 0.30 0.30 0.30 0.45 0.65 0.40 0.60 0.85 0.60 0.90 1.30 (iv) Beam quality and half-value layer (HVL). Table 2 X-ray Tube Voltage (kilovolt peak) and Minimum HVL Designed Operating Range (kV) Measured Operating Voltage (kV) Minimum HVL (millimeters of aluminum) Below 50 20 0.20 25 0.25 30 0.30 (v) Breast entrance air kerma and AEC reproducibility. (vi) Dosimetry. (vii) X-ray field/light field/image receptor/compression paddle alignment. (B) If a light field that passes through the X-ray beam limitation device is provided, it shall be aligned with the X-ray field so that the total of any misalignment of the edges of the light field and the X-ray field along either the length or the width of the visually defined field at the plane of the breast support surface shall not exceed 2 percent of the SID. (C) The chest wall edge of the compression paddle shall not extend beyond the chest wall edge of the image receptor by more than one percent of the SID when tested with the compression paddle placed above the breast support surface at a distance equivalent to standard breast thickness. The shadow of the vertical edge of the compression paddle shall not be visible on the image. (viii) Uniformity of screen speed. (ix) System artifacts. (x) Radiation output. (B) The system shall be capable of maintaining the required minimum radiation output averaged over a 3.0 second period. (xi) Decompression. (A) An override capability to allow maintenance of compression; (B) A continuous display of the override status; and (C) A manual emergency compression release that can be activated in the event of power or automatic release failure. (6) Quality control tests—other modalities. (7) Mobile units. (8) Use of test results. (ii) If the test results fall outside of the action limits, the source of the problem shall be identified and corrective actions shall be taken: (A) Before any further examinations are performed or any films are processed using a component of the mammography system that failed any of the tests described in paragraphs (e)(1), (e)(2), (e)(4)(i), (e)(4)(ii), (e)(4)(iii), (e)(5)(vi), (e)(6), or (e)(7) of this section; (B) Within 30 days of the test date for all other tests described in paragraph (e) of this section. (9) Surveys. (ii) The results of all tests conducted by the facility in accordance with paragraphs (e)(1) through (e)(7) of this section, as well as written documentation of any corrective actions taken and their results, shall be evaluated for adequacy by the medical physicist performing the survey. (iii) The medical physicist shall prepare a survey report that includes a summary of this review and recommendations for necessary improvements. (iv) The survey report shall be sent to the facility within 30 days of the date of the survey. (v) The survey report shall be dated and signed by the medical physicist performing or supervising the survey. If the survey was performed entirely or in part by another individual under the direct supervision of the medical physicist, that individual and the part of the survey that individual performed shall also be identified in the survey report. (10) Mammography equipment evaluations. (11) Facility cleanliness. (ii) The facility shall document that all cleaning procedures are performed at the frequencies specified in the protocols. (12) Calibration of air kerma measuring instruments. (13) Infection control. (i) Comply with all applicable Federal, State, and local regulations pertaining to infection control; and (ii) Comply with the manufacturer's recommended procedures for the cleaning and disinfection of the mammography equipment used in the facility; or (iii) If adequate manufacturer's recommendations are not available, comply with generally accepted guidance on infection control, until such recommendations become available. (f) Quality assurance-mammography medical outcomes audit. (1) General requirements. (i) Positive predictive value—percent of patients with positive mammograms who are diagnosed with breast cancer within 1 year of the date of the mammographic examination. (ii) Cancer detection rate—of the patients initially examined with screening mammograms who receive an assessment of “Incomplete: Need additional imaging evaluation,” “Suspicious,” or “Highly Suggestive of Malignancy” on the screening mammogram or on a subsequent diagnostic mammogram, the number of patients who are diagnosed with breast cancer within 1 year of the date of the initial screening mammogram, expressed arithmetically as a ratio per 1,000 patients. (iii) Recall rate—percentage of screening mammograms given an assessment of “Incomplete: Need additional imaging evaluation.” (2) Frequency of audit analysis. (3) Audit interpreting physician. (4) The records and data required to demonstrate compliance with the requirements in paragraphs (f)(1) through (3) of this section must be retained until the annual inspection that follows the facility's analysis of that information. (g) Mammographic procedure and techniques for mammography of patients with breast implants. (2) Except where contraindicated, or unless modified by a physician's directions, patients with breast implants undergoing mammography shall have mammographic views to maximize the visualization of breast tissue. (h) Consumer complaint mechanism. (1) Establish a written and documented system for collecting and resolving consumer complaints; (2) Maintain a record of each serious complaint received by the facility for at least 3 years from the date the complaint was received; (3) Provide the consumer with adequate directions for filing serious complaints with the facility's accreditation body if the facility is unable to resolve a serious complaint to the consumer's satisfaction; (4) Report unresolved serious complaints to the accreditation body in a manner and timeframe specified by the accreditation body. (i) Clinical image quality. (j) Additional mammography review and patient and referring provider notification. (2) Based on the results of the additional mammography review, the facility's failure to comply with the terms of the additional mammography review, or other information, FDA or the State certification agency may determine that the quality of mammography performed by a facility, whether or not certified under § 900.11, was so inconsistent with the quality standards established in this part as to present a significant risk to human health. FDA or the State certification agency may require such a facility to notify all patients who received mammograms at the facility or those patients who are determined to be at risk due to the quality of their mammography, and their referring physicians or other healthcare providers, of the deficiencies and resulting potential harm, appropriate remedial measures, and such other relevant information as FDA or the State certification agency may require. Such notification shall occur within a timeframe and in a manner specified by FDA or the State certification agency. If the facility is unable or unwilling to perform such notification, FDA or the State certification agency may notify patients and their referring physicians or other healthcare providers individually or through the mass media. [62 FR 55976, Oct. 28, 1997; 62 FR 60614, Nov. 10, 1997, as amended at 63 FR 56558, Oct. 22, 1998; 64 FR 18333, Apr. 14, 1999; 64 FR 32408, June 17, 1999; 65 FR 43690, July 14, 2000; 88 FR 15168, Mar. 10, 2023] § 900.13 Revocation of accreditation and revocation of accreditation body approval. (a) FDA action following revocation of accreditation. (b) Withdrawal of FDA approval of an accreditation body. (2) After 1 year from the date of withdrawal of approval of an accreditation body, or within any shorter period of time established by the agency, the affected facilities must obtain accreditation from another accreditation body, or from another entity designated by FDA. § 900.14 Suspension or revocation of certificates. (a) Except as provided in paragraph (b) of this section, FDA may suspend or revoke a certificate if FDA finds, after providing the owner or operator of the facility with notice and opportunity for a hearing in accordance with part 16 of this chapter, that the facility, owner, operator, or any employee of the facility: (1) Has been guilty of misrepresentation in obtaining the certificate; (2) Has failed to comply with the standards of § 900.12; (3) Has failed to comply with reasonable requests of FDA, the State certification agency, or the accreditation body for records, information, reports, or materials, including clinical images for an additional mammography review under § 900.12(j), that FDA or the State certification agency believes are necessary to determine the continued eligibility of the facility for a certificate or continued compliance with the standards of § 900.12; (4) Has refused a reasonable request of a duly designated FDA inspector, State inspector, or accreditation body representative for permission to inspect the facility or the operations and pertinent records of the facility; (5) Has violated or aided and abetted in the violation of any provision of or regulation issued pursuant to 42 U.S.C. 263b; (6) Has failed to comply with prior sanctions imposed by FDA or the State certification agency under 42 U.S.C. 263b(h), including a directed plan of correction or a patient and referring physician notification; or (7) Has failed to comply with requests of current or former facility personnel for records of their training or experience relevant to their qualification under MQSA, in violation of § 900.12(a)(4). (b) FDA may suspend the certificate of a facility before holding a hearing if FDA makes a finding described in paragraph (a) of this section and also determines that; (1) The failure to comply with required standards presents a serious risk to human health; (2) The refusal to permit inspection makes immediate suspension necessary; or (3) There is reason to believe that the violation or aiding and abetting of the violation was intentional or associated with fraud. (c) If FDA suspends a certificate in accordance with paragraph (b) of this section: (1) The agency shall provide the facility with an opportunity for an informal hearing under part 16 of this chapter not later than 60 days from the effective date of this suspension; (2) The suspension shall remain in effect until the agency determines that: (i) Allegations of violations or misconduct were not substantiated; (ii) Violations of required standards have been corrected to the agency's satisfaction; or (iii) The facility's certificate is revoked in accordance with paragraph (d) of this section; (d) After providing a hearing in accordance with paragraph (c)(1) of this section, the agency may revoke the facility's certificate if the agency determines that the facility: (1) Is unwilling or unable to correct violations that were the basis for suspension; or (2) Has engaged in fraudulent activity to obtain or continue certification. [62 FR 55976, Oct. 28, 1997. Republished and corrected at 62 FR 60614, Nov. 10, 1997, as amended at 88 FR 15171, Mar. 10, 2023] § 900.15 Appeals of adverse accreditation or reaccreditation decisions that preclude certification or recertification. (a) The appeals procedures described in this section are available only for adverse accreditation or reaccreditation decisions that preclude certification or recertification by FDA. Agency decisions to suspend or revoke certificates that are already in effect will be handled in accordance with § 900.14. (b) Upon learning that a facility has failed to become accredited or reaccredited, FDA will notify the facility that the agency is unable to certify that facility without proof of accreditation. (c) A facility that has been denied accreditation or reaccreditation is entitled to an appeals process from the accreditation body, in accordance with § 900.7. A facility must avail itself of the accreditation body's appeal process before requesting reconsideration from FDA. (d) A facility that cannot achieve satisfactory resolution of an adverse accreditation decision through the accreditation body's appeal process is entitled to further appeal in accordance with procedures set forth in this section and in regulations published in 42 CFR part 498. (1) References to the Centers for Medicare and Medicaid Services in 42 CFR part 498 should be read as the Division of Mammography Quality Standards (DMQS), Center for Devices and Radiological Health, Food and Drug Administration. (2) References to the Appeals Council of the Social Security Administration in 42 CFR part 498 should be read as references to the Departmental Appeals Board. (3) In accordance with the procedures set forth in subpart B of 42 CFR part 498, a facility that has been denied accreditation following appeal to the accreditation body may request reconsideration of that adverse decision from DMQRP. (i) A facility must request reconsideration by DMQS within 60 days of the accreditation body's adverse appeals decision, at the following address: Food and Drug Administration, Center for Devices and Radiological Health, Division of Mammography Quality Standards, Attn: Facility Accreditation Review Committee, 10903 New Hampshire Ave., Bldg. 66, Rm. 3621, Silver Spring, MD 20993-0002. (ii) The request for reconsideration shall include three copies of the following records: (A) The accreditation body's original denial of accreditation. (B) All information the facility submitted to the accreditation body as part of the appeals process; (C) A copy of the accreditation body's adverse appeals decision; and (D) A statement of the basis for the facility's disagreement with the accreditation body's decision. (iii) DMQRP will conduct its reconsideration in accordance with the procedures set forth in subpart B of 42 CFR part 498. (4) A facility that is dissatisfied with DMQRP's decision following reconsideration is entitled to a formal hearing in accordance with procedures set forth in subpart D of 42 CFR part 498. (5) Either the facility or FDA may request review of the hearing officer's decision. Such review will be conducted by the Departmental Appeals Board in accordance with subpart E of 42 CFR part 498. (6) A facility cannot perform mammography services while an adverse accreditation decision is being appealed. [62 FR 55976, Oct. 28, 1997; 62 FR 60614, Nov. 10, 1997, as amended at 75 FR 20916, Apr. 22, 2010; 85 FR 18443, Apr. 2, 2020; 88 FR 15171, Mar. 10, 2023] § 900.16 Appeals of denials of certification. (a) The appeals procedures described in this section are available only to facilities that are denied certification by FDA after they have been accredited by an approved accreditation body. Appeals for facilities that have failed to become accredited are governed by the procedures set forth in § 900.15. (b) FDA may deny the application if the agency has reason to believe that: (1) The facility will not be operated in accordance with standards established under § 900.12; (2) The facility will not permit inspections or provide access to records or information in a timely fashion; or (3) The facility has been guilty of misrepresentation in obtaining the accreditation. (c)(1) If FDA denies an application for certification by a faciity that has received accreditation from an approved accreditation body, FDA shall provide the facility with a statement of the grounds on which the denial is based. (2) A facility that has been denied accreditation may request reconsideration and appeal of FDA's determination in accordance with the applicable provisions of § 900.15(d). § 900.17 [Reserved] § 900.18 Alternative requirements for § 900.12 quality standards. (a) Criteria for approval of alternative standards. (1) The proposed alternative standard will be at least as effective in assuring quality mammography as the standard it proposes to replace, and (2) The proposed alternative: (i) Is too limited in its applicability to justify an amendment to the standard; or (ii) Offers an expected benefit to human health that is so great that the time required for amending the standard would present an unjustifiable risk to the human health; and (3) The granting of the alternative is in keeping with the purposes of 42 U.S.C. 263b. (b) Applicants for alternatives. (2) Federal agencies and State governments that are not accreditation bodies may apply for alternatives to the standards of § 900.12(a). (3) Manufacturers and assemblers of equipment used for mammography may apply for alternatives to the standards of § 900.12(b) and (e). (c) Applications for approval of an alternative standard. (1) Identification of the original standard for which the alternative standard is being proposed and an explanation of why the applicant is proposing the alternative; (2) A description of the manner in which the alternative is proposed to deviate from the original standard; (3) A description, supported by data, of the advantages to be derived from such deviation; (4) An explanation, supported by data, of how such a deviation would ensure equal or greater quality of production, processing, or interpretation of mammograms than the original standard; (5) The suggested period of time that the proposed alternative standard would be in effect; and (6) Such other information required by the Director to evaluate and act on the application. (d) Ruling on applications. (2) Notice of an approved request for an alternative standard or any amendment or extension thereof shall be placed in the public docket file in the Dockets Management Staff and may also be in the form of a notice published in the Federal Register. (3) Summaries of the approval of alternative standards, including information on their nature and number, shall be provided to the National Mammography Quality Assurance Advisory Committee. (4) All applications for approval of alternative standards and for amendments and extensions thereof and all correspondence (including written notices of approval) on these applications shall be available for public disclosure in the Dockets Management Staff, excluding patient identifiers and confidential commercial information. (e) Amendment or extension of an alternative standard. (1) The approval number and the expiration date of the alternative standard; (2) The amendment or extension requested and the basis for the amendment or extension; and (3) An explanation, supported by data, of how such an amendment or extension would ensure equal or greater quality of production, processing, or interpretation of mammograms than the original standard. (f) Applicability of the alternative standards. (2) When an alternative standard is approved for a manufacturer of equipment, any facility using that equipment will also be covered by the alternative standard. (3) The agency may extend the alternative standard to other entities when FDA determines that expansion of the approval of the alternative standard would be an effective means of promoting the acceptance of measures to improve the quality of mammography. All such determinations will be publicized by appropriate means. (g) Withdrawal of approval of alternative requirements. [62 FR 55976, Oct. 28, 1997; 62 FR 60614, Nov. 10, 1997, as amended at 75 FR 20916, Apr. 22, 2010; 85 FR 18444, Apr. 2, 2020; 88 FR 45067, July 14, 2023] Subpart C—States as Certifiers Source: 67 FR 5467, Feb. 6, 2002, unless otherwise noted. § 900.20 Scope. The regulations set forth in this part implement the Mammography Quality Standards Act (MQSA) (42 U.S.C. 263b). Subpart C of this part establishes procedures whereby a State can apply to become a FDA-approved certification agency to certify facilities within the State to perform mammography services. Subpart C of this part further establishes requirements and standards for State certification agencies to ensure that all mammography facilities under their jurisdiction are adequately and consistently evaluated for compliance with quality standards at least as stringent as the national quality standards established by FDA. § 900.21 Application for approval as a certification agency. (a) Eligibility. (b) Application for approval. (2) Following receipt of the written request, FDA will provide the applicant with additional information to aid in the submission of an application for approval as a certification agency. (3) The applicant shall furnish to FDA, at the address in paragraph (b)(1) of this section, three copies of an application containing the following information, materials, and supporting documentation: (i) Name, address, and phone number of the applicant; (ii) Detailed description of the mammography quality standards the applicant will require facilities to meet and, for those standards different from FDA's quality standards, information substantiating that they are at least as stringent as FDA standards under § 900.12; (iii) Detailed description of the applicant's review and decisionmaking process for facility certification, including: (A) Policies and procedures for notifying facilities of certificate denials and expirations; (B) Procedures for monitoring and enforcement of the correction of deficiencies by facilities; (C) Policies and procedures for suspending or revoking a facility's certification; (D) Policies and procedures that will ensure processing certificates within a timeframe approved by FDA; (E) A description of the appeals process for facilities contesting adverse certification status decisions; (F) Education, experience, and training requirements of the applicant's professional and supervisory staff; (G) Description of the applicant's electronic data management and analysis system; (H) Fee schedules; (I) Statement of policies and procedures established to avoid conflict of interest; (J) Description of the applicant's mechanism for handling facility inquiries and complaints; (K) Description of a plan to ensure that certified mammography facilities will be inspected according to MQSA (42 U.S.C. 263b) and procedures and policies for notifying facilities of inspection deficiencies; (L) Policies and procedures for monitoring and enforcing the correction of facility deficiencies discovered during inspections or by other means; (M) Policies and procedures for additional mammography review and for requesting such reviews from accreditation bodies; (N) Policies and procedures for patient notification; (O) If a State has regulations that are more stringent than those of § 900.12, an explanation of how adverse actions taken against a facility under the more stringent regulations will be distinguished from those taken under the requirements of § 900.12; and (P) Any other information that FDA identifies as necessary to make a determination on the approval of the State as a certification agency. (c) Rulings on applications for approval. (2) FDA will notify the applicant of any deficiencies in the application and request that those deficiencies be corrected within a specified time period. If the deficiencies are not corrected to FDA's satisfaction within the specified time period, FDA may deny the application for approval as a certification agency. (3) FDA shall notify the applicant whether the application has been approved or denied. The notification shall list any conditions associated with approval or state the bases for any denial. (4) The review of any application may include a meeting between FDA and representatives of the applicant at a time and location mutually acceptable to FDA and the applicant. (5) FDA will advise the applicant of the circumstances under which a denied application may be resubmitted. (d) Scope of authority. [62 FR 55976, Oct. 28, 1997; 62 FR 60614, Nov. 10, 1997, as amended at 75 FR 20916, Apr. 22, 2010; 85 FR 18444, Apr. 2, 2020] § 900.22 Standards for certification agencies. The certification agency shall accept the following responsibilities in order to ensure quality mammography at the facilities it certifies and shall perform these responsibilities in a manner that ensures the integrity and impartiality of the certification agency's actions: (a) Conflict of interest. (b) Certification and inspection responsibilities. (c) Compliance with quality standards. (d) Enforcement actions. (2) There shall be prompt investigation of and appropriate enforcement action for facilities performing mammography without certificates. (e) Appeals. (f) Additional mammography review. (g) Patient notification. (h) Electronic data transmission. (i) Changes to standards. § 900.23 Evaluation. FDA shall evaluate annually the performance of each certification agency. The evaluation shall include the use of performance indicators that address the adequacy of program performance in certification, inspection, and enforcement activities. FDA will also consider any additional information deemed relevant by FDA that has been provided by the certification body or other sources or has been required by FDA as part of its oversight mandate. The evaluation also shall include a review of any changes in the standards or procedures in the areas listed in §§ 900.21(b) and 900.22 that have taken place since the original application or the last evaluation, whichever is most recent. The evaluation shall include a determination of whether there are major deficiencies in the certification agency's regulations or performance that, if not corrected, would warrant withdrawal of the approval of the certification agency under the provisions of § 900.24, or minor deficiencies that would require corrective action. § 900.24 Withdrawal of approval. If FDA determines, through the evaluation activities of § 900.23, or through other means, that a certification agency is not in substantial compliance with this subpart, FDA may initiate the following actions: (a) Major deficiencies. (1) FDA shall notify the certification agency of FDA's action and the grounds on which the approval was withdrawn. (2) A certification agency that has lost its approval shall notify facilities certified or seeking certification by it, as well as the appropriate accreditation bodies with jurisdiction in the State, that its approval has been withdrawn. Such notification shall be made within a timeframe and in a manner approved by FDA. (b) Minor deficiencies. (1) If FDA places a certification agency on probationary status, the certification agency shall notify all facilities certified or seeking certification by it of its probationary status within a time period and in a manner approved by FDA. (2) Probationary status shall remain in effect until such time as the certification agency can demonstrate to the satisfaction of FDA that it has successfully implemented or is implementing the corrective action plan within the established schedule, and that the corrective actions have substantially eliminated all identified problems, or (3) If FDA determines that a certification agency that has been placed on probationary status is not implementing corrective actions satisfactorily or within the established schedule, FDA may withdraw approval of the certification agency. The certification agency shall notify all facilities certified or seeking certification by it, as well as the appropriate accreditation bodies with jurisdiction in the State, of its loss of FDA approval, within a timeframe and in a manner approved by FDA. (c) Transfer of records. § 900.25 Hearings and appeals. (a) Opportunities to challenge final adverse actions taken by FDA regarding approval of certification agencies or withdrawal of approval of certification agencies shall be communicated through notices of opportunity for informal hearings in accordance with part 16 of this chapter. (b) A facility that has been denied certification is entitled to an appeals process from the certification agency. The appeals process shall be specified in writing by the certification agency and shall have been approved by FDA in accordance with §§ 900.21 and 900.22.

Related documents

• 50 CFR Part 600 — Magnuson-Stevens Act Provisions#512148
• 50 CFR Part 622 — Fisheries of the Caribbean, Gulf of America, and South Atlantic#512149
• 50 CFR Part 635 — Atlantic Highly Migratory Species#512150
• 50 CFR Part 648 — Fisheries of the Northeastern United States#512151
• 50 CFR Part 660 — Fisheries off West Coast States#512152