PART 800—GENERAL Authority: 21 U.S.C. 321, 334, 351, 352, 355, 360e, 360i, 360j, 360k, 361, 362, 371. Section 800.30 also issued under Sec. 709, Pub. L. 115-52, 131 Stat. 1065-67. Subpart A [Reserved] Subpart B—Requirements for Specific Medical Devices § 800.10 Contact lens solutions; sterility. (a)(1) Informed medical opinion is in agreement that all preparations offered or intended for ophthalmic use, including contact lens solutions, should be sterile. It is further evident that such preparations purport to be of such purity and quality as to be suitable for safe use in the eye. (2) The Food and Drug Administration concludes that all such preparations, if they are not sterile, fall below their professed standard of purity or quality and may be unsafe. In a statement of policy issued on September 1, 1964, the Food and Drug Administration ruled that liquid preparations offered or intended for ophthalmic use that are not sterile may be regarded as adulterated within the meaning of section 501(c) of the Federal Food, Drug, and Cosmetic Act (the act), and, further, may be deemed misbranded within the meaning of section 502(j) of the act. By this regulation, this ruling is applicable to all preparations for ophthalmic use that are regulated as medical devices, i.e., contact lens solutions. By the regulation in § 200.50 of this chapter, this ruling is applicable to ophthalmic preparations that are regulated as drugs. (3) The containers shall be sterile at the time of filling and closing, and the container or individual carton shall be so sealed that the contents cannot be used without destroying the seal. The packaging and labeling of these solutions shall also comply with § 800.12 on tamper-resistant packaging requirements. (b) Liquid ophthalmic preparations packed in multiple-dose containers should: (1) Contain one or more suitable and harmless substances that will inhibit the growth of microorganisms; or (2) Be so packaged as to volume and type of container and so labeled as to duration of use and with such necessary warnings as to afford adequate protection and minimize the hazard of injury resulting from contamination during use. (c) Eye cups, eye droppers, and other dispensers intended for ophthalmic use should be sterile, and may be regarded as falling below their professed standard of purity or quality if they are not sterile. These articles, which are regulated as medical devices unless packaged with the drugs with which they are to be used, should be packaged so as to maintain sterility until the package is opened and be labeled, on or within the retail package, so as to afford adequate directions and necessary warnings to minimize the hazard of injury resulting from contamination during use. [47 FR 50455, Nov. 5, 1982] § 800.12 Contact lens solutions and tablets; tamper-resistant packaging. (a) General. (b) Requirement for tamper-resistant package. (c) Labeling. (d) Requests for exemptions from packaging and labeling requirements. (e) Products subject to approved premarket approval applications. (f) Effective date. (1) Initial effective date for packaging requirements. (ii) The packaging requirement in paragraph (b) of this section is effective on May 5, 1983 for each tablet that is to be used to make a contact lens solution and that is packaged for retail sale on or after that date. (2) Initial effective date for labeling requirements. (3) Retail level effective date. [47 FR 50455, Nov. 5, 1982; 48 FR 1706, Jan. 14, 1983, as amended at 48 FR 16666, Apr. 19, 1983; 48 FR 37625, Aug. 19, 1983; 53 FR 11252, Apr. 6, 1988; 73 FR 34859, June 19, 2008] Effective Date Note: A document published at 48 FR 41579, Sept. 16, 1983, stayed the effective date of § 800.12(f)(3) until further notice. § 800.20 Patient examination gloves and surgeons' gloves; sample plans and test method for leakage defects; adulteration. (a) Purpose. (1) For a description of a patient examination glove, see § 880.6250. Finger cots, however, are excluded from the test method and sample plans in paragraphs (b) and (c) of this section. (2) For a description of a surgeons' glove, see § 878.4460 of this chapter. (b)(1) General test method. (i) Units examined. (ii) Identification of defects. (iii) Factors for counting defects. (2) Leak test materials. (i) A 60 mm by 380 mm (clear) plastic cylinder with a hook on one end and a mark scored 40 mm from the other end (a cylinder of another size may be used if it accommodates both cuff diameter and any water above the glove capacity); (ii) Elastic strapping with velcro or other fastening material; (iii) Automatic water-dispensing apparatus or manual device capable of delivering 1,000 ml of water; (iv) Stand with horizontal rod for hanging the hook end of the plastic tube. The horizontal support rod must be capable of holding the weight of the total number of gloves that will be suspended at any one time, e.g., five gloves suspended will weigh about 5 kilograms (kg); (v) Timer capable of measuring two minute intervals. (3) Visual defects and leak test procedures. (i) Visual defects examination. (ii) Leak test set-up. (B) Add 1,000 ml of room temperature water (i.e., 20 (deg)C to 30 (deg)C) into the open end of the fill tube. The water should pass freely into the glove. (With some larger sizes of long-cuffed surgeons' gloves, the water level may reach only the base of the thumb. With some smaller gloves, the water level may extend several inches up the fill tube.) (iii) Leak test examination. (A) If the glove does not leak immediately, keep the glove/filling tube assembly upright and hang the assembly vertically from the horizontal rod, using the wire hook on the open end of the fill tube (do not support the filled glove while transferring). (B) Make a second observation for leaks 2 minutes after the water is added to the glove. Use only minimum manipulation of the fingers to check for leaks. (C) Record the number of defective gloves. (c) Sampling, inspection, acceptance, and adulteration. (1) Sample plans. (2) Sample sizes, inspection levels, and minimum AQLs. (3) Adulteration levels and accept/reject criteria. Accept/Reject Criteria at 1.5 AQL for Surgeons' Gloves Lot Size Sample Sample Size Number Examined Number Defective Accept Reject 8 to 90 Single sample 8 0 1 91 to 280 Single sample 32 1 2 281 to 500 Single sample 50 2 3 501 to 1,200 Single sample 80 3 4 1,201 to 3,200 First 32 32 — 4 Second 32 64 1 5 Third 32 96 2 6 Fourth 32 128 3 7 Fifth 32 160 5 8 Sixth 32 192 7 9 Seventh 32 224 9 10 3,201 to 10,000 First 50 50 0 4 Second 50 100 1 6 Third 50 150 3 8 Fourth 50 200 5 10 Fifth 50 250 7 11 Sixth 50 300 10 12 Seventh 50 350 13 14 10,001 to 35,000 First 80 80 0 5 Second 80 160 3 8 Third 80 240 6 10 Fourth 80 320 8 13 Fifth 80 400 11 15 Sixth 80 480 14 17 Seventh 80 560 18 19 35,000 First 125 125 1 7 Second 125 250 4 10 Third 125 375 8 13 Fourth 125 500 12 17 Fifth 125 625 17 20 Sixth 125 750 21 23 Seventh 125 875 25 26 Accept/Reject Criteria at 2.5 AQL for Patient Examination Gloves Lot Size Sample Sample Size Number Examined Number Defective Accept Reject 5 to 50 Single sample 5 0 1 51 to 150 Single sample 20 1 2 151 to 280 Single sample 32 2 3 281 to 500 Single sample 50 3 4 501 to 1,200 Single sample 80 5 6 1,201 to 3,200 First 32 32 0 4 Second 32 64 1 6 Third 32 96 3 8 Fourth 32 128 5 10 Fifth 32 160 7 11 Sixth 32 192 10 12 Seventh 32 224 13 14 3,201 to 10,000 First 50 50 0 5 Second 50 100 3 8 Third 50 150 6 10 Fourth 50 200 8 13 Fifth 50 250 11 15 Sixth 50 300 14 17 Seventh 50 350 18 19 10,001 to 35,000 First 80 80 1 7 Second 80 160 4 10 Third 80 240 8 13 Fourth 80 320 12 17 Fifth 80 400 17 20 Sixth 80 480 21 23 Seventh 80 560 25 26 35,000 and above First 125 125 2 9 Second 125 250 7 14 Third 125 375 13 19 Fourth 125 500 19 25 Fifth 125 625 25 29 Sixth 125 750 31 33 Seventh 125 875 37 38 (d) Compliance. (1) Detention and seizure. (2) Reconditioning. (i) Modified sampling, inspection, and acceptance. (A) General inspection level II, (B) Single sampling plans for tightened inspection, (C) 1.5 AQL for surgeons' gloves, and (D) 2.5 AQL for patient examination gloves. (ii) Adulteration levels and acceptance criteria for reconditioned gloves. (B) FDA considers a reconditioned lot of medical gloves to be adulterated within the meaning of section 501(c) of the act when the number of defective gloves found in the tested sample meets or exceeds the applicable rejection number in the tables following paragraph (d)(2)(ii)(B) of this section: Accept/Reject Criteria at 1.5 AQL for Reconditioned Surgeons' Gloves Lot Size Sample Sample Size Number Defective Accept Reject 13 to 90 Single sample 13 0 1 91 to 500 Single sample 50 1 2 501 to 1,200 Single sample 80 2 3 1,201 to 3,200 Single sample 125 3 4 3,201 to 10,000 Single sample 200 5 6 10,001 to 35,000 Single sample 315 8 9 35,000 and above Single sample 500 12 13 Accept/Reject Criteria at 2.5 AQL for Reconditioned Patient Examination Gloves Lot Size Sample Sample Size Number Defective Accept Reject 8 to 50 Single sample 8 0 1 51 to 280 Single sample 32 1 2 281 to 500 Single sample 50 2 3 501 to 1,200 Single sample 80 3 4 1,201 to 3,200 Single sample 125 5 6 3,201 to 10,000 Single sample 200 8 9 10,001 to 35,000 Single sample 315 12 13 35,000 and above Single sample 500 18 19 [55 FR 51256, Dec. 12, 1990, as amended at 71 FR 75876, Dec. 19, 2006] § 800.30 Over-the-counter hearing aid controls. (a) Scope. (b) Definitions for the purposes of this section. Air-conduction hearing aid. Hearing aid. Licensed person. Over-the-counter hearing aid. Prescription hearing aid. Rebuilt hearing aid. Sale. Tools, tests, or software. Used hearing aid. (c) Labeling. (1) Outside package labeling. (i) Warnings and other important information. (A) (A) Warning against use in people younger than 18. (B) Symptoms suggesting perceived mild to moderate hearing loss. (C) Advice of availability of professional services. (D) “Red flag” conditions. (E) Notice of contact information. (F) Notice of manufacturer's return policy. (ii) Statement of build condition. (iii) Statement of OTC availability. (iv) Indication of battery information. (v) Indication of control platform. (2) Labeling, inside the package. (i) The following warnings, which shall appear in the following order and prior to any content except the cover page: (A) Warning against use in people younger than 18. (B) “Red flag” conditions. (C) Warning about pain from device placement. (ii) Any additional warnings the manufacturer may include prior to the cautions and notices to users in paragraph (c)(2)(iii) of this section. (iii) The following cautions and notices for users, which shall appear prior to any content except the cover page and the warnings under paragraphs (c)(2)(i) and (ii) of this section: (A) Caution about hearing protection. (B) Caution about excessive sound output. (C) Caution about components lodging in ear. (D) Advice to seek professional services. (E) Note about user expectations. (E) Note about reporting adverse events to FDA. (iv) An illustration(s) of the OTC hearing aid that indicates operating controls, user adjustments, and the battery compartment. (v) Information on the function of all controls intended for user adjustment. (vi) A description of any accessory that accompanies the OTC hearing aid, including but not limited to wax guards and accessories for use with a computer, television, or telephone. (vii) Specific instructions for all of the following: (A) Instructions for sizing or inserting the eartip of the OTC hearing aid to prevent insertion past the depth limit and damage to the tympanic membrane. (B) The tools, tests, or software that allow the user to control the OTC hearing aid, including self-selection and self-checking the performance of the OTC hearing aid, and customize it to the user's hearing needs, including information about properly fitting eartips. (C) Use of the OTC hearing aid with any accompanying accessories. (D) Maintenance and care of the OTC hearing aid, including how a lay user can clean, disinfect, and replace parts or how to seek replacements, as well as how to store the hearing aid when it will not be used for an extended period of time. (E) If the battery is replaceable or rechargeable, how to replace or recharge the battery, including a generic designation of replacement batteries. (F) Expected battery life. (G) Any other information necessary for adequate directions for use as defined in § 801.5 of this chapter. (viii) Identification of any known physiological side effects associated with the use of the OTC hearing aid that may warrant consultation with a physician, referring to an ear-nose-throat doctor when preferable, including if applicable, skin irritation and accelerated accumulation of cerumen (ear wax). (ix) The technical specifications required by paragraph (c)(4) of this section. (x) A description of commonly occurring, avoidable events that could adversely affect or damage the OTC hearing aid, including but not limited to, as applicable, ear wax buildup, drops, immersion in water, or exposure to excessive heat. (xi) If the hearing aid incorporates wireless technology in its programming or use, appropriate warnings, instructions, and information relating to electromagnetic compatibility and wireless technology and human exposure to non-ionizing radiation. (xii) Information on how and where to obtain repair service or replacements, including at least one specific address where the user can go or send the OTC hearing aid to obtain such repair service or replacements. (xiii) If clinical or non-clinical studies were conducted by or for the manufacturer to support the performance of the OTC hearing aid, a summary of all such studies. (3) Labeling on the device. (i) The serial number. (ii) If the battery is removable, a “+” symbol to indicate the positive terminal for battery insertion unless the battery's physical design prevents inserting the battery in the reversed position. (iii) If the OTC hearing aid is used or rebuilt, the manufacturer shall physically attach a removable tag to the hearing aid declaring that fact. (4) Technical specifications. (i) The maximum output limit value (Output Sound Pressure Level 90 (OSPL90)). (ii) The full-on gain value, which is the gain with a 50 decibel (dB) Sound Pressure Level (SPL) pure-tone input and volume set to full on. (iii) The total harmonic distortion value. (iv) The self-generated noise value. (v) The latency value. (vi) The upper and lower cutoff frequencies for bandwidth. (5) Software device labeling. e.g., (i) Prior to first use of the software or obtaining payment information for the software, whichever occurs first, the labeling must clearly and prominently present all of the following to the prospective user. For each, the labeling must remain visible until the user dismisses it or proceeds to the next step: (A) Compatibility and minimum operating requirements for the software device. (B) Disclosures of any fees or payments after first use or initial payment, including but not limited to any fees or payments relating to subscriptions, add-on features, or continued access to features or services. The disclosures must name and briefly describe what each fee or payment covers. (C) The information required under paragraphs (c)(1)(i), (iii), and (v) of this section. (ii) Prior to first use of the software, the labeling must clearly and prominently present all of the following to the prospective user: (A) The information required under paragraph (c)(2)(i)(A) of this section, and it must remain visible until the user acknowledges it. (B) The information required under paragraphs (c)(2)(i)(B) and (C), (c)(2)(ii), (iii), and (v), (c)(2)(vii)(B) and (G), and (c)(2)(viii) and (ix) of this section, and the information must remain visible until the user dismisses it or proceeds to the next step. (C) All other information required under paragraph (c)(2) of this section, to the extent applicable, and the information must remain visible until the user dismisses it or proceeds to the next step. (iii) The software device labeling must include the information required under paragraphs (c)(3)(i) and (c)(4) of this section. (iv) All of the software device labeling must be accessible for review after acknowledgment, dismissal, or proceeding to the next step. (v) If there are changes to any of the labeling required under paragraph (c)(5) of this section, the labeling with the changed information must be presented to the user until the user dismisses it. (d) Output limits. (1) General output limit. (2) Output limit for a device with activated input-controlled compression. (e) Electroacoustic performance limits. (1) Output distortion control limits. (i) The total harmonic distortion plus noise shall not exceed 5 percent for output levels within one of the following sets of levels, depending on the test method: (A) Using sine wave-based testing, measure at 70 dB SPL and 100 dB SPL; or (B) Using a 500-hertz (Hz) one-third-octave pulsed-noise signal, measure at 67 dB SPL and 97 dB SPL. (ii) You must measure the total harmonic distortion using a 500-Hz input tone with an analyzer that has a bandwidth at least as wide as the frequency limits of the OTC hearing aid. (iii) You must measure the output distortion at the OTC hearing aid's maximum volume and the input sound level to the OTC hearing aid adjusted to produce the required outputs. (2) Self-generated noise level limits. (3) Latency. (4) Frequency response bandwidth. (5) Frequency response smoothness. (6) Acoustic coupler choice. (i) When compatible with the device design, a 2-cubic centimeter (cm 3 (ii) When a 2-cm 3 (f) Design requirements. (1) Insertion depth. (2) Use of atraumatic materials. (3) Proper physical fit. (4) Tools, tests, or software. (5) User-adjustable volume control. (6) Adequate reprocessing. (g) Conditions for sale of an OTC hearing aid. (1) Age minimum. (2) Statement of OTC availability. (h) Effect on State law. (1) Preemption. (2) Professional requirements General rule. (ii) Sale of OTC hearing aids is not an exemption. (iii) Representations may create professional obligations. (3) Private remedies. (i) Incorporation by reference. [email protected], www.archives.gov/federal-register/cfr/ibr-locations.html. [email protected], www.cta.tech [87 FR 50748, Aug. 17, 2022] Subpart C—Administrative Practices and Procedures § 800.55 Administrative detention. (a) General. (b) Criteria for ordering detention. (c) Detention period. (d) Issuance of detention order. (2) If detention of devices in a vehicle or other carrier is ordered, a copy of the detention order shall be provided to the shipper of record and the owner of the vehicle or other carrier, if their identities can be readily determined. (3) The detention order shall include the following information: (i) A statement that the devices identified in the order are detained for the period shown; (ii) A brief, general statement of the reasons for the detention; (iii) The location of the devices; (iv) A statement that these devices are not to be used, moved, altered, or tampered with in any manner during that period, except as permitted under paragraph (h) of this section, without the written permission of an authorized FDA representative; (v) Identification of the detained devices; (vi) The detention order number; (vii) The date and hour of the detention order; (viii) The period of the detention; (ix) The text of section 304(g) of the act and paragraph (g) (1) and (2) of this section; (x) A statement that any informal hearing on an appeal of a detention order shall be conducted as a regulatory hearing under part 16 of this chapter, with certain exceptions described in paragraph (g)(3) of this section; and (xi) The mailing address, telephone number, and name of the FDA Division Director. (e) Approval of detention order. (f) Labeling or marking a detained device. (1) A statement that the devices are detained by the United States Government in accordance with section 304(g) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 334(g)). (2) A statement that the devices shall not be used, moved, altered, or tampered with in any manner for the period shown, without the written permission of an authorized FDA representative, except as authorized in paragraph (h) of this section. (3) A statement that the violation of a detention order or the removal or alteration of the tag is punishable by fine or imprisonment or both (section 303 of the act, 21 U.S.C. 333). (4) The detention order number, the date and hour of the detention order, the detention period, and the name of the FDA representative who issued the detention order. (g) Appeal of a detention order. (2) The appellant of a detention order shall state the ownership or proprietary interest the appellant has in the detained devices. If the detained devices are located at a place other than an establishment owned or operated by the appellant, the appellant shall include documents showing that the appellant would have legitimate authority to claim the devices if seized. (3) Any informal hearing on an appeal of a detention order shall be conducted as a regulatory hearing pursuant to regulation in accordance with part 16 of this chapter, except that: (i) The detention order under paragraph (d) of this section, rather than the notice under § 16.22(a) of this chapter, provides notice of opportunity for a hearing under this section and is part of the administrative record of the regulatory hearing under § 16.80(a) of this chapter. (ii) A request for a hearing under this section should be addressed to the FDA Division Director. (iii) The last sentence of § 16.24(e) of this chapter, stating that a hearing may not be required to be held at a time less than 2 working days after receipt of the request for a hearing, does not apply to a hearing under this section. (iv) Paragraph (g)(4) of this section, rather than § 16.42(a) of this chapter, describes the FDA employees who preside at hearings under this section. (4) The presiding officer of a regulatory hearing on an appeal of a detention order, who also shall decide the appeal, shall be an Office of Regulatory Affairs Program Director or another FDA official senior to an FDA Division Director who is permitted by § 16.42(a) of this chapter to preside over the hearing. (5) If the appellant requests a regulatory hearing and requests that the hearing be held within 5 working days after the appeal is filed, the presiding officer shall, within 5 working days, hold the hearing and render a decision affirming or revoking the detention. (6) If the appellant requests a regulatory hearing and requests that the hearing be held at a date later than within 5 working days after the appeal is filed, but not later than 20 calendar days after receipt of a detention order, the presiding officer shall hold the hearing at a date agreed upon by FDA and the appellant. The presiding officer shall decide whether to affirm or revoke the detention within 5 working days after the conclusion of the hearing. The detention period extends to the date of the decision even if the 5-working-day period for making the decision extends beyond the otherwise applicable 20-calendar-day or 30-calendar-day detention period. (7) If the appellant appeals the detention order but does not request a regulatory hearing, the presiding officer shall render a decision on the appeal affirming or revoking the detention within 5 working days after the filing of the appeal. (8) If the presiding officer affirms a detention order, the devices continue to be detained until FDA terminates the detention under paragraph (j) of this section or the detention period expires, whichever occurs first. (9) If the presiding officer revokes a detention order, FDA shall terminate the detention under paragraph (j) of this section. (h) Movement of detained devices. (2) If detained devices are not in final form for shipment, the manufacturer may move them within the establishment where they are detained to complete the work needed to put them in final form. As soon as the devices are moved for the purpose of the preceding sentence, the individual responsible for their movement shall orally notify the FDA representative who issued the detention order, or another responsible division office official, of the movement of the devices. As soon as the devices are put in final form, they shall be segregated from other devices, and the individual responsible for their movement shall orally notify the FDA representative who issued the detention order, or another responsible division office official, of their new location. The devices put in final form shall not be moved further without FDA approval. (3) The FDA representative who issued the detention order, or another responsible division office official, may approve, in writing, the movement of detained devices for any of the following purposes: (i) To prevent interference with an establishment's operations or harm to the devices. (ii) To destroy the devices. (iii) To bring the devices into compliance. (iv) For any other purpose that the FDA representative who issued the detention order, or other responsible division office official, believes is appropriate in the case. (4) If an FDA representative approves the movement of detained devices under paragraph (h)(3) of this section, the detained devices shall remain segregated from other devices and the person responsible for their movement shall immediately orally notify the official who approved the movement of the devices, or another responsible FDA division office official, of the new location of the detained devices. (5) Unless otherwise permitted by the FDA representative who is notified of, or who approves, the movement of devices under this paragraph, the required tags shall accompany the devices during and after movement and shall remain with the devices until FDA terminates the detention or the detention period expires, whichever occurs first. (i) Actions involving adulterated or misbranded devices. (j) Detention termination. (k) Recordkeeping requirements. (2) Records required under this paragraph shall be maintained for a maximum period of 2 years after the issuance of the detention order or for such other shorter period as FDA directs. When FDA terminates the detention or when the detention period expires, whichever occurs first, FDA will advise all persons required under this paragraph to keep records concerning that detention whether further recordkeeping is required for the remainder of the 2-year, or shorter, period. FDA ordinarily will not require further recordkeeping if the agency determines that the devices are not adulterated or misbranded or that recordkeeping is not necessary to protect the public health, unless the records are required under other regulations in this chapter (e.g., the good manufacturing practice regulation in part 820 of this chapter). [44 FR 13239, Mar. 9, 1979, as amended at 49 FR 3174, Jan. 26, 1984; 69 FR 17292, Apr. 2, 2004; 79 FR 9412, Feb. 19, 2014; 82 FR 14147, Mar. 17, 2017; 85 FR 16555, Mar. 25, 2020] § 800.75 Requests for supervisory review of certain decisions made by the Center for Devices and Radiological Health. (a) Definitions. (1) FDA (2) 517A decision (i) A substantially equivalent order under § 807.100(a)(1) of this chapter, or a not substantially equivalent order under § 807.100(a)(2) of this chapter; (ii) An approval order under § 814.44(d) of this chapter, an approvable letter under § 814.44(e) of this chapter, a not approvable letter under § 814.44(f) of this chapter, or an order denying approval under § 814.45 of this chapter; (iii) An approval order under § 814.116(b) of this chapter, an approvable letter under § 814.116(c) of this chapter, a not approvable letter under § 814.116(d) of this chapter, or an order denying approval under § 814.118 of this chapter; (iv) A grant or denial of a request for breakthrough device designation under section 515B of the Federal Food, Drug, and Cosmetic Act; (v) An approval order under § 812.30(a) of this chapter or a disapproval order under § 812.30(c) of this chapter; (vi) A failure to reach agreement letter under section 520(g)(7) of the Federal Food, Drug, and Cosmetic Act; or (vii) A clinical hold determination under section 520(g)(8) of the Federal Food, Drug, and Cosmetic Act. (3) CDRH (b) Submission of request Review of 517A decisions (ii) A person requesting supervisory review under paragraph (b)(1)(i) may request an in-person meeting or teleconference with the supervisor reviewing the request for supervisory review. Except as provided in paragraph (b)(1)(iii) of this section, if a request for in-person meeting or teleconference is included in the request for supervisory review to CDRH, CDRH will schedule the meeting or teleconference to occur within 30 days of receipt of the request. Except as provided in paragraph (b)(1)(iii) of this section, a decision will be rendered within 30 days of such meeting or teleconference. (iii) The timeframes for CDRH to render a decision provided in (b)(1)(i) and (ii) of this section, and the timeframe to schedule an in-person meeting or teleconference review in (b)(1)(ii) of this section, do not apply if a matter related to the 517A decision under review is referred by CDRH to external experts, such as an advisory committee, as provided in § 10.75(b) of this chapter. (2) Supervisory review. [email protected] [84 FR 31477, July 2, 2019]