PART 892—RADIOLOGY DEVICES Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, Source: 53 FR 1567, Jan. 20, 1988, unless otherwise noted. Editorial Note: Nomenclature changes to part 892 appear at 73 FR 35341, June 23, 2008. Subpart A—General Provisions § 892.1 Scope. (a) This part sets forth the classification of radiology devices intended for human use that are in commercial distribution. (b) The identification of a device in a regulation in this part is not a precise description of every device that is, or will be, subject to the regulation. A manufacturer who submits a premarket notification submission for a device under part 807 cannot show merely that the device is accurately described by the section title and identification provision of a regulation in this part but shall state why the device is substantially equivalent to other devices, as required by § 807.87. (c) To avoid duplicative listings, a radiology device that has two or more types of uses (e.g., use both as a diagnostic device and a therapeutic device) is listed in one subpart only. (d) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of this title 21, unless otherwise noted. (e) Guidance documents referenced in this part are available on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm.. [53 FR 1567, Jan. 20, 1988, as amended at 73 FR 40969, July 17, 2008; 78 FR 18233, Mar. 26, 2013] § 892.3 Effective dates of requirement for premarket approval. A device included in this part that is classified into class III (premarket approval) shall not be commercially distributed after the date shown in the regulation classifying the device unless the manufacturer has an approval under section 515 of the act (unless an exemption has been granted under section 520(g)(2) of the act). An approval under section 515 of the act consists of FDA's issuance of an order approving an application for premarket approval (PMA) for the device or declaring completed a product development protocol (PDP) for the device. (a) Before FDA requires that a device commercially distributed before the enactment date of the amendments, or a device that has been found substantially equivalent to such a device, has an approval under section 515 of the act, FDA must promulgate a regulation under section 515(b) of the act requiring such approval, except as provided in paragraph (b) of this section. Such a regulation under section 515(b) of the act shall not be effective during the grace period ending on the 90th day after its promulgation or on the last day of the 30th full calendar month after the regulation that classifies the device into class III is effective, whichever is later. See section 501(f)(2)(B) of the act. Accordingly, unless an effective date of the requirement for premarket approval is shown in the regulation for a device classified into class III in this part, the device may be commercially distributed without FDA's issuance of an order approving a PMA or declaring completed a PDP for the device. If FDA promulgates a regulation under section 515(b) of the act requiring premarket approval for a device, section 501(f)(1)(A) of the act applies to the device. (b) Any new, not substantially equivalent, device introduced into commercial distribution on or after May 28, 1976, including a device formerly marketed that has been substantially altered, is classified by statute (section 513(f) of the act) into class III without any grace period and FDA must have issued an order approving a PMA or declaring completed a PDP for the device before the device is commercially distributed unless it is reclassified. If FDA knows that a device being commercially distributed may be a “new” device as defined in this section because of any new intended use or other reasons, FDA may codify the statutory classification of the device into class III for such new use. Accordingly, the regulation for such a class III device states that as of the enactment date of the amendments, May 28, 1976, the device must have an approval under section 515 of the act before commercial distribution. § 892.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). The exemption from the requirement of premarket notification (section 510(k) of the act) for a generic type of class I or II device is only to the extent that the device has existing or reasonably foreseeable characteristics of commercially distributed devices within that generic type or, in the case of in vitro diagnostic devices, only to the extent that misdiagnosis as a result of using the device would not be associated with high morbidity or mortality. Accordingly, manufacturers of any commercially distributed class I or II device for which FDA has granted an exemption from the requirement of premarket notification must still submit a premarket notification to FDA before introducing or delivering for introduction into interstate commerce for commercial distribution the device when: (a) The device is intended for a use different from the intended use of a legally marketed device in that generic type of device; e.g., the device is intended for a different medical purpose, or the device is intended for lay use where the former intended use was by health care professionals only; (b) The modified device operates using a different fundamental scientific technology than a legally marketed device in that generic type of device; e.g., a surgical instrument cuts tissue with a laser beam rather than with a sharpened metal blade, or an in vitro diagnostic device detects or identifies infectious agents by using deoxyribonucleic acid (DNA) probe or nucleic acid hybridization technology rather than culture or immunoassay technology; or (c) The device is an in vitro device that is intended: (1) For use in the diagnosis, monitoring, or screening of neoplastic diseases with the exception of immunohistochemical devices; (2) For use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of metabolism; (3) For measuring an analyte that serves as a surrogate marker for screening, diagnosis, or monitoring life-threatening diseases such as acquired immune deficiency syndrome (AIDS), chronic or active hepatitis, tuberculosis, or myocardial infarction or to monitor therapy; (4) For assessing the risk of cardiovascular diseases; (5) For use in diabetes management; (6) For identifying or inferring the identity of a microorganism directly from clinical material; (7) For detection of antibodies to microorganisms other than immunoglobulin G (IgG) or IgG assays when the results are not qualitative, or are used to determine immunity, or the assay is intended for use in matrices other than serum or plasma; (8) For noninvasive testing as defined in § 812.3(k) of this chapter; and (9) For near patient testing (point of care). [65 FR 2322, Jan. 14, 2000] Subpart B—Diagnostic Devices § 892.1000 Magnetic resonance diagnostic device. (a) Identification. (b) Classification. [53 FR 5078, Feb. 1, 1989, as amended at 84 FR 71818, Dec. 30, 2019] § 892.1001 Liver iron concentration imaging companion diagnostic for deferasirox. (a) Identification. (b) Classification. (1) Design verification and validation must include nonclinical and clinical performance testing demonstrating the bias, precision, repeatability, and reproducibility of liver iron concentration measurements. (2) Labeling must include specifying: (i) Instructions for acceptance testing of images prior to processing; (ii) Data processing quality assurance protocols; and (iii) The sensitivity and specificity of liver iron concentration measurements. [90 FR 40735, Aug. 21, 2025] § 892.1100 Scintillation (gamma) camera. (a) Identification. (b) Classification. [55 FR 48443, Nov. 20, 1990, as amended at 66 FR 46953, Sept. 10, 2001] § 892.1110 Positron camera. (a) Identification. (b) Classification. [55 FR 48444, Nov. 20, 1990, as amended at 66 FR 46953, Sept. 10, 2001] § 892.1130 Nuclear whole body counter. (a) Identification. (b) Classification. [53 FR 1567, Jan. 20, 1988, as amended at 59 FR 63015, Dec. 7, 1994; 66 FR 38818, July 25, 2001] [55 FR 48444, Nov. 20, 1990] § 892.1170 Bone densitometer. (a) Identification. (b) Classification. § 892.1180 Bone sonometer. (a) Identification. (b) Classification. [73 FR 40969, July 17, 2008] § 892.1200 Emission computed tomography system. (a) Identification. (b) Classification. § 892.1220 Fluorescent scanner. (a) Identification. (b) Classification. § 892.1300 Nuclear rectilinear scanner. (a) Identification. (b) Classification. [55 FR 48444, Nov. 20, 1990, as amended at 65 FR 2322, Jan. 14, 2000; 66 FR 38818, July 25, 2001] § 892.1310 Nuclear tomography system. (a) Identification. (b) Classification. § 892.1320 Nuclear uptake probe. (a) Identification. (b) Classification. [55 FR 48444, Nov. 20, 1990, as amended at 65 FR 2322, Jan. 14, 2000] § 892.1330 Nuclear whole body scanner. (a) Identification. (b) Classification. [55 FR 48444, Nov. 20, 1990, as amended at 65 FR 2322, Jan. 14, 2000] § 892.1350 Nuclear scanning bed. (a) Identification. (b) Classification. [55 FR 48444, Nov. 20, 1990, as amended at 59 FR 63015, Dec. 7, 1994; 65 FR 2322, Jan. 14, 2000] § 892.1360 Radionuclide dose calibrator. (a) Identification. (b) Classification. § 892.1370 Nuclear anthropomorphic phantom. (a) Identification. (b) Classification. [53 FR 1567, Jan. 20, 1988, as amended at 54 FR 13832, Apr. 5, 1989; 66 FR 38818, July 25, 2001] § 892.1380 Nuclear flood source phantom. (a) Identification. (b) Classification. [53 FR 1567, Jan. 20, 1988, as amended at 54 FR 13832, Apr. 5, 1989; 66 FR 38819, July 25, 2001] § 892.1390 Radionuclide rebreathing system. (a) Identification. (b) Classification. § 892.1400 Nuclear sealed calibration source. (a) Identification. (b) Classification. [53 FR 1567, Jan. 20, 1988, as amended at 54 FR 13832, Apr. 5, 1989; 66 FR 38819, July 25, 2001] § 892.1410 Nuclear electrocardiograph synchronizer. (a) Identification. (b) Classification. [55 FR 48444, Nov. 20, 1990, as amended at 65 FR 2322, Jan. 14, 2000] § 892.1420 Radionuclide test pattern phantom. (a) Identification. (b) Classification. [53 FR 1567, Jan. 20, 1988, as amended at 54 FR 13832, Apr. 5, 1989; 66 FR 38819, July 25, 2001] § 892.1540 Nonfetal ultrasonic monitor. (a) Identification. (b) Classification. § 892.1550 Ultrasonic pulsed doppler imaging system. (a) Identification. (b) Classification. § 892.1560 Ultrasonic pulsed echo imaging system. (a) Identification. (b) Classification. [48 FR 53047, Nov. 23, 1983, as amended at 84 FR 71818, Dec. 30, 2019] § 892.1570 Diagnostic ultrasonic transducer. (a) Identification. (b) Classification. § 892.1600 Angiographic x-ray system. (a) Identification. (b) Classification. § 892.1610 Diagnostic x-ray beam-limiting device. (a) Identification. (b) Classification. [48 FR 53047, Nov. 23, 1983, as amended at 84 FR 71818, Dec. 30, 2019] § 892.1620 Cine or spot fluorographic x-ray camera. (a) Identification. (b) Classification. § 892.1630 Electrostatic x-ray imaging system. (a) Identification. (b) Classification. § 892.1640 Radiographic film marking system. (a) Identification. (b) Classification. [55 FR 48444, Nov. 20, 1990, as amended at 59 FR 63015, Dec. 7, 1994; 66 FR 38819, July 25, 2001] § 892.1650 Image-intensified fluoroscopic x-ray system. (a) Identification. (b) Classification. [53 FR 1567, Jan. 20, 1988, as amended at 66 FR 57369, Nov. 15, 2001; 84 FR 71818, Dec. 30, 2019] § 892.1660 Non-image-intensified fluoroscopic x-ray system. (a) Identification. (b) Classification. § 892.1670 Spot-film device. (a) Identification. (b) Classification. [48 FR 53047, Nov. 23, 1983, as amended at 84 FR 71818, Dec. 30, 2019] § 892.1680 Stationary x-ray system. (a) Identification. (b) Classification. [48 FR 53047, Nov. 23, 1983, as amended at 84 FR 71818, Dec. 30, 2019] § 892.1700 Diagnostic x-ray high voltage generator. (a) Identification. (b) Classification. [53 FR 1567, Jan. 20, 1988, as amended at 61 FR 1125, Jan. 16, 1996; 66 FR 38819, July 25, 2001] § 892.1710 Mammographic x-ray system. (a) Identification. (b) Classification. § 892.1715 Full-field digital mammography system. (a) Identification. (b) Classification. See [75 FR 68203, Nov. 5, 2010] § 892.1720 Mobile x-ray system. (a) Identification. (b) Classification. § 892.1730 Photofluorographic x-ray system. (a) Identification. (b) Classification. [48 FR 53047, Nov. 23, 1983, as amended at 84 FR 71819, Dec. 30, 2019] § 892.1740 Tomographic x-ray system. (a) Identification. (b) Classification. § 892.1750 Computed tomography x-ray system. (a) Identification. (b) Classification. § 892.1760 Diagnostic x-ray tube housing assembly. (a) Identification. (b) Classification. [53 FR 1567, Jan. 20, 1988, as amended at 61 FR 1125, Jan. 16, 1996; 66 FR 38819, July 25, 2001] § 892.1770 Diagnostic x-ray tube mount. (a) Identification. (b) Classification. [53 FR 1567, Jan. 20, 1988, as amended at 61 FR 1125, Jan. 16, 1996; 66 FR 38819, July 25, 2001] § 892.1820 Pneumoencephalographic chair. (a) Identification. (b) Classification. [48 FR 53047, Nov. 23, 1983, as amended at 84 FR 71819, Dec. 30, 2019] § 892.1830 Radiologic patient cradle. (a) Identification. (b) Classification. [53 FR 1567, Jan. 20, 1988, as amended at 61 FR 1125, Jan. 16, 1996; 66 FR 38819, July 25, 2001] § 892.1840 Radiographic film. (a) Identification. (b) Classification. [53 FR 1567, Jan. 20, 1988, as amended at 66 FR 38819, July 25, 2001] § 892.1850 Radiographic film cassette. (a) Identification. (b) Classification. [48 FR 53047, Nov. 23, 1983, as amended at 84 FR 71819, Dec. 30, 2019] § 892.1860 Radiographic film/cassette changer. (a) Identification. (b) Classification. [48 FR 53047, Nov. 23, 1983, as amended at 84 FR 71819, Dec. 30, 2019] § 892.1870 Radiographic film/cassette changer programmer. (a) Identification. (b) Classification. [48 FR 53047, Nov. 23, 1983, as amended at 84 FR 71819, Dec. 30, 2019] § 892.1880 Wall-mounted radiographic cassette holder. (a) Identification. (b) Classification. [53 FR 1567, Jan. 20, 1988, as amended at 61 FR 1125, Jan. 16, 1996; 66 FR 38819, July 25, 2001] § 892.1890 Radiographic film illuminator. (a) Identification. (b) Classification. [55 FR 48444, Nov. 20, 1990, as amended at 65 FR 2323, Jan. 14, 2000] § 892.1900 Automatic radiographic film processor. (a) Identification. (b) Classification. [55 FR 48444, Nov. 20, 1990, as amended at 84 FR 71819, Dec. 30, 2019] § 892.1910 Radiographic grid. (a) Identification. (b) Classification. [53 FR 1567, Jan. 20, 1988, as amended at 65 FR 2323, Jan. 14, 2000] § 892.1920 Radiographic head holder. (a) Identification. (b) Classification. [53 FR 1567, Jan. 20, 1988, as amended at 66 FR 38819, July 25, 2001; 90 FR 55995, Dec. 4, 2025] § 892.1940 Radiologic quality assurance instrument. (a) Identification. (b) Classification. [53 FR 1567, Jan. 20, 1988, as amended at 66 FR 38819, July 25, 2001; 90 FR 55995, Dec. 4, 2025] § 892.1950 Radiographic anthropomorphic phantom. (a) Identification. (b) Classification. [53 FR 1567, Jan. 20, 1988, as amended at 66 FR 38819, July 25, 2001; 90 FR 55995, Dec. 4, 2025] § 892.1960 Radiographic intensifying screen. (a) Identification. (b) Classification. [53 FR 1567, Jan. 20, 1988, as amended at 65 FR 2323, Jan. 14, 2000] § 892.1970 Radiographic ECG/respirator synchronizer. (a) Identification. (b) Classification. [55 FR 48444, Nov. 20, 1990, as amended at 65 FR 2323, Jan. 14, 2000] § 892.1980 Radiologic table. (a) Identification. (b) Classification. [53 FR 1567, Jan. 20, 1988, as amended at 63 FR 59231, Nov. 3, 1998] § 892.1990 Transilluminator for breast evaluation. (a) Identification. (b) Classification. (c) Date premarket approval (PMA) or notice of completion of product development protocol (PDP) is required. [60 FR 36639, July 18, 1995, as amended at 79 FR 3094, Jan. 17, 2014] § 892.2010 Medical image storage device. (a) Identification: (b) Classification. [63 FR 23387, Apr. 29, 1998; 63 FR 44998, Aug. 24, 1998, as amended at 65 FR 2323, Jan. 14, 2000; 86 FR 20284, Apr. 19, 2021] § 892.2020 Medical image communications device. (a) Identification. (b) Classification. [63 FR 23387, Apr. 29, 1998; 63 FR 44998, Aug. 24, 1998, as amended at 65 FR 2323, Jan. 14, 2000, 86 FR 20283, Apr. 19, 2021] § 892.2030 Medical image digitizer. (a) Identification. (b) Classification. [63 FR 23387, Apr. 29, 1998, as amended at 84 FR 71819, Dec. 30, 2019] § 892.2040 Medical image hardcopy device. (a) Identification. (b) Classification. [63 FR 23387, Apr. 29, 1998, as amended at 84 FR 71819, Dec. 30, 2019] § 892.2050 Medical image management and processing system. (a) Identification. (b) Classification. [63 FR 23387, Apr. 29, 1998, as amended at 86 FR 20284, Apr. 19, 2021] § 892.2055 Radiological machine learning-based quantitative imaging software with predetermined change control plan. (a) Identification. (b) Classification. (1) Design verification and validation must include: (i) A detailed description of the image postprocessing algorithms, including a detailed description of the algorithm inputs and outputs, each major component or block, and algorithm limitations. (ii) Detailed description of training data including detailed annotation methods and important cohorts ( e.g., (iii) Performance testing protocols and results that demonstrate that the underlying algorithms function as intended. The performance assessment must be based on objective performance measures ( e.g., e.g., (iv) Software verification, validation, and hazard analysis. (2) As part of the design verification and validation activities, you must document the planned device modifications of the quantitative imaging software, and the associated methodology for the development, verification, and validation of modifications made consistent with the performance requirements in the plan. (3) As part of the risk management activities, you must identify and assess the risks of the planned modification(s) and identify corresponding risk mitigations. (4) Labeling must include: (i) A detailed description of the patient population for which the device was validated; (ii) A description of the intended user and expertise needed for safe use of the device; (iii) A detailed description of the device inputs and outputs; (iv) A detailed description of compatible imaging hardware and imaging protocols; (v) A detailed summary of the current performance of the device and a summary of the performance testing conducted to support safe and effective use of the device including test methods, dataset characteristics (including demographics), testing environment, results (with confidence intervals), and a summary of sub-analyses on case distributions stratified by relevant confounders; (vi) A description of situations in which the device may fail or may not operate at its expected performance level ( e.g., (vii) Labeling related to the predetermined change control plan (PCCP), including: (A) A statement that the device has a PCCP; (B) A description of modification(s) implemented for quantitative imaging and supporting algorithms, including a summary of current performance, associated inputs, validation requirements, and related evidence; and (C) A version history, a description of how device modification(s) will be implemented, and a description of how users will be informed of device modification(s) made in accordance with the PCCP. [91 FR 36524, June 17, 2026] § 892.2060 Radiological computer-assisted diagnostic software for lesions suspicious of cancer. (a) Identification. (b) Classification. (1) Design verification and validation must include: (i) A detailed description of the image analysis algorithms including, but not limited to, a detailed description of the algorithm inputs and outputs, each major component or block, and algorithm limitations. (ii) A detailed description of pre-specified performance testing protocols and dataset(s) used to assess whether the device will improve reader performance as intended. (iii) Results from performance testing protocols that demonstrate that the device improves reader performance in the intended use population when used in accordance with the instructions for use. The performance assessment must be based on appropriate diagnostic accuracy measures ( e.g., e.g., (iv) Standalone performance testing protocols and results of the device. (v) Appropriate software documentation ( e.g., (2) Labeling must include: (i) A detailed description of the patient population for which the device is indicated for use. (ii) A detailed description of the intended reading protocol. (iii) A detailed description of the intended user and recommended user training. (iv) A detailed description of the device inputs and outputs. (v) A detailed description of compatible imaging hardware and imaging protocols. (vi) Warnings, precautions, and limitations, including situations in which the device may fail or may not operate at its expected performance level ( e.g., (vii) Detailed instructions for use. (viii) A detailed summary of the performance testing, including: Test methods, dataset characteristics, results, and a summary of sub-analyses on case distributions stratified by relevant confounders ( e.g., [85 FR 3542, Jan. 22, 2020] § 892.2070 Medical image analyzer. (a) Identification. (b) Classification. (1) Design verification and validation must include: (i) A detailed description of the image analysis algorithms including a description of the algorithm inputs and outputs, each major component or block, and algorithm limitations. (ii) A detailed description of pre-specified performance testing methods and dataset(s) used to assess whether the device will improve reader performance as intended and to characterize the standalone device performance. Performance testing includes one or more standalone tests, side-by-side comparisons, or a reader study, as applicable. (iii) Results from performance testing that demonstrate that the device improves reader performance in the intended use population when used in accordance with the instructions for use. The performance assessment must be based on appropriate diagnostic accuracy measures ( e.g., e.g., (iv) Appropriate software documentation ( e.g., (2) Labeling must include the following: (i) A detailed description of the patient population for which the device is indicated for use. (ii) A detailed description of the intended reading protocol. (iii) A detailed description of the intended user and user training that addresses appropriate reading protocols for the device. (iv) A detailed description of the device inputs and outputs. (v) A detailed description of compatible imaging hardware and imaging protocols. (vi) Discussion of warnings, precautions, and limitations must include situations in which the device may fail or may not operate at its expected performance level ( e.g., (vii) Device operating instructions. (viii) A detailed summary of the performance testing, including: test methods, dataset characteristics, results, and a summary of sub-analyses on case distributions stratified by relevant confounders, such as lesion and organ characteristics, disease stages, and imaging equipment. [85 FR 3548, Jan. 22, 2020] § 892.2080 Radiological computer aided triage and notification software. (a) Identification. (b) Classification. (1) Design verification and validation must include: (i) A detailed description of the notification and triage algorithms and all underlying image analysis algorithms including, but not limited to, a detailed description of the algorithm inputs and outputs, each major component or block, how the algorithm affects or relates to clinical practice or patient care, and any algorithm limitations. (ii) A detailed description of pre-specified performance testing protocols and dataset(s) used to assess whether the device will provide effective triage ( e.g., (iii) Results from performance testing that demonstrate that the device will provide effective triage. The performance assessment must be based on an appropriate measure to estimate the clinical effectiveness. The test dataset must contain sufficient numbers of cases from important cohorts ( e.g., (iv) Stand-alone performance testing protocols and results of the device. (v) Appropriate software documentation ( e.g., (2) Labeling must include the following: (i) A detailed description of the patient population for which the device is indicated for use; (ii) A detailed description of the intended user and user training that addresses appropriate use protocols for the device; (iii) Discussion of warnings, precautions, and limitations must include situations in which the device may fail or may not operate at its expected performance level ( e.g., (iv) A detailed description of compatible imaging hardware, imaging protocols, and requirements for input images; (v) Device operating instructions; and (vi) A detailed summary of the performance testing, including: test methods, dataset characteristics, triage effectiveness ( e.g., e.g., [85 FR 3544, Jan. 22, 2020] § 892.2090 Radiological computer-assisted detection and diagnosis software. (a) Identification. e.g., (b) Classification. (1) Design verification and validation must include: (i) A detailed description of the image analysis algorithm, including a description of the algorithm inputs and outputs, each major component or block, how the algorithm and output affects or relates to clinical practice or patient care, and any algorithm limitations. (ii) A detailed description of pre-specified performance testing protocols and dataset(s) used to assess whether the device will provide improved assisted-read detection and diagnostic performance as intended in the indicated user population(s), and to characterize the standalone device performance for labeling. Performance testing includes standalone test(s), side-by-side comparison(s), and/or a reader study, as applicable. (iii) Results from standalone performance testing used to characterize the independent performance of the device separate from aided user performance. The performance assessment must be based on appropriate diagnostic accuracy measures ( e.g., e.g., (iv) Results from performance testing that demonstrate that the device provides improved assisted-read detection and/or diagnostic performance as intended in the indicated user population(s) when used in accordance with the instructions for use. The reader population must be comprised of the intended user population in terms of clinical training, certification, and years of experience. The performance assessment must be based on appropriate diagnostic accuracy measures ( e.g., (v) Appropriate software documentation, including device hazard analysis, software requirements specification document, software design specification document, traceability analysis, system level test protocol, pass/fail criteria, testing results, and cybersecurity measures. (2) Labeling must include the following: (i) A detailed description of the patient population for which the device is indicated for use. (ii) A detailed description of the device instructions for use, including the intended reading protocol and how the user should interpret the device output. (iii) A detailed description of the intended user, and any user training materials or programs that address appropriate reading protocols for the device, to ensure that the end user is fully aware of how to interpret and apply the device output. (iv) A detailed description of the device inputs and outputs. (v) A detailed description of compatible imaging hardware and imaging protocols. (vi) Warnings, precautions, and limitations must include situations in which the device may fail or may not operate at its expected performance level ( e.g., (vii) A detailed summary of the performance testing, including test methods, dataset characteristics, results, and a summary of sub-analyses on case distributions stratified by relevant confounders, such as anatomical characteristics, patient demographics and medical history, user experience, and imaging equipment. [90 FR 24970, June 13, 2025] 892.2100 Radiological acquisition and/or optimization guidance system. 892.2100 Radiological acquisition and/or optimization guidance system. (a) Identification. (b) Classification. (1) Design verification and validation must include: (i) A detailed, technical device description, including a detailed description of the impact of any software and hardware on the device's functions, the associated capabilities and limitations of each part, and the associated inputs and outputs. (ii) A detailed, technical report on the non-clinical performance testing of the subject device in the intended use environments, using relevant consensus standards when applicable. (iii) A detailed report on the clinical performance testing, obtained from either clinical testing, accepted virtual/physical systems designed to capture clinical variability, comparison to a closely-related device with established clinical performance, or other sources that are justified appropriately. The choice of the method must be justified given the risk of the device and the general acceptance of the test methods. The report must include the following: (A) A thorough description of the testing protocol(s). (B) A thorough, quantitative evaluation of the diagnostic utility and quality of images/data acquired, or optimized, using the device. (C) A thorough, quantitative evaluation of the performance in a representative user population and patient population, under anticipated conditions and environments of use. (D) A thorough discussion on the generalizability of the clinical performance testing results. (E) A thorough discussion on use-related risk analysis/human factors data. (iv) A detailed protocol that describes, in the event of a future change, the level of change in the device technical specifications or indications for use at which the change or changes could significantly affect the safety or effectiveness of the device and the risks posed by these changes. The assessment metrics, acceptance criteria, and analytical methods used for the performance testing of changes that are within the scope of the protocol must be included. (v) Documentation of an appropriate training program, including instructions on how to acquire and process quality images and video clips, and a report on usability testing demonstrating the effectiveness of that training program on user performance, including acquiring and processing quality images. (2) The labeling required under § 801.109(c) of this chapter must include: (i) A detailed description of the device, including information on all required and/or compatible parts. (ii) A detailed description of the patient population for which the device is indicated for use. (iii) A detailed description of the intended user population, and the recommended user training. (iv) Detailed instructions for use, including the information provided in the training program used to meet the requirements of paragraph (b)(1)(iv) of this section. (v) A warning that the images and data acquired using the device are to be interpreted only by qualified medical professionals. (vi) A detailed summary of the reports required under paragraphs (b)(1)(ii) and (iii) of this section. (vii) A statement on upholding the As Low As Reasonably Achievable (ALARA) principle with a discussion on the associated device controls/options. [90 FR 23285, June 2, 2025] Subparts C-E [Reserved] Subpart F—Therapeutic Devices § 892.5050 Medical charged-particle radiation therapy system. (a) Identification. (b) Classification. [53 FR 1567, Jan. 20, 1988, as amended at 64 FR 1125, Jan. 8, 1999] § 892.5060 Fludeoxyglucose F18-guided radiation therapy system. (a) Identification. (b) Classification. (1) An analysis must be provided of any effects on safety or effectiveness based on differences that exist in the use ( i.e., (2) Design verification and validation activities must include monitoring of changes to the labeling and formulation of fludeoxyglucose F18, and addressing such changes so that they do not adversely affect the safety and effectiveness of the device and fludeoxyglucose F18 when used with the device. (3) Clinical performance testing must demonstrate that the system performs as intended under anticipated conditions of use, including demonstrating: adequate reader performance for distinguishing patients with eligible versus ineligible radiopharmaceutical biodistribution on imaging; reproducibility across fractions; and sufficient signal strength to meet system sensitivity requirements. Clinical performance testing under anticipated conditions of use must evaluate: dose ranging for identification of lowest safe and adequate dose; and all adverse events. (4) Non-clinical performance testing under anticipated conditions of use must demonstrate: (i) Compatibility of the linear accelerator and the tomography scanner; (ii) Adequate positron emission tomography (PET) imaging performance for patient selection in comparison with a legally marketed diagnostic scanner's output; (iii) Adequacy of the chosen imaging metrics for inter- and intra-fractional treatment delivery; and (iv) Dosimetric concurrence between delivered dose distributions and treatment plan, including comparison of delivery isolating difference between guidance on and off conditions. (5) Performance testing must demonstrate the electrical safety and electromagnetic compatibility of any electrical components. (6) Software verification, validation, and hazard analysis must be performed for any software components of the device. Software documentation must include a detailed description of the dose delivery tracking algorithms, including the dose calculation methods, treatment boundaries, treatment delivery fluence calculation methods, system latency for moving targets, interface for post-treatment review, limitations of the algorithm, and accompanying verification and validation testing to ensure device and algorithm functionality as informed by the software requirements and hazard analysis. (7) A training program must be included to ensure users can correctly interpret images to determine patient eligibility. (8) The labeling must include the following: (i) A detailed description of the patient population included in clinical testing specifying age, primary cancer type, cancer stage, and target volume locations and sizes; (ii) A dedicated imaging agent section which includes a description of the use of fludeoxyglucose F18 with the device and a statement in the indications for use informing users where full prescribing information is available for fludeoxyglucose F18 in the current approved drug labeling and in the device labeling; (iii) Detailed instructions for use of fludeoxyglucose F18 with the device to guide radiation therapy, including: uptake time needed, time window to deliver treatment, physician review of pre-delivery safety checks, image interpretation, tissue targeted for fludeoxyglucose F18 uptake, pre-treatment image criteria to determine patient eligibility, and other differences compared to the current approved fludeoxyglucose F18 drug labeling; (iv) A detailed summary of the performance testing required under paragraphs (b)(3) and (b)(4) of this section, including test methods, dataset characteristics, and results; (v) A detailed description of the user workflow; and (vi) An instruction for users to plan for an alternative treatment if pre-treatment evaluation fails. [91 FR 50710, Aug. 6, 2026] § 892.5300 Medical neutron radiation therapy system. (a) Identification. (b) Classification. § 892.5650 Manual radionuclide applicator system. (a) Identification. (b) Classification. [53 FR 1567, Jan. 20, 1988, as amended at 65 FR 2323, Jan. 14, 2000] § 892.5700 Remote controlled radionuclide applicator system. (a) Identification. (b) Classification. § 892.5710 Radiation therapy beam-shaping block. (a) Identification. (b) Classification. § 892.5720 Rectal balloon for prostate immobilization. (a) Identification. (b) Classification. (1) The premarket notification submission must include methodology and results of the following non-clinical and clinical performance testing: (i) Biocompatibility testing of the final finished device; (ii) If provided sterile, sterilization validation; (iii) If not provided sterile, bioburden testing of the final finished device; (iv) Shelf life and expiration date validation; and (v) Performance testing including but not limited to: (A) Venting mechanism (if device has a vent mechanism); (B) Safety mechanism(s) to prevent advancement beyond its intended safe placement; and (C) Structural integrity testing ( e.g., (2) Labeling that includes: (i) Appropriate warnings and contraindications, including, but not limited to the following statements: (A) “Do not transport the patient with the rectal balloon inserted. The balloon should be removed prior to transport.”; (B) “Failure to perform the standard imaging position verification protocol may cause the device to not perform as intended.”; (C) “Reduce the rectal balloon fill volume if the patient experiences discomfort due to the rectal balloon inflation.”; and (D) “Do not apply excessive pressure/force on the shaft or tubing of the rectal balloon.” (ii) Adequate instructions for use on the proper insertion procedure, positioning, and inflation of the rectal balloon; (iii) Whether the device is sterile or non-sterile; and (iv) An expiration date. [82 FR 61171, Dec. 27, 2017] § 892.5725 Absorbable perirectal spacer. (a) Identification. (b) Classification. (1) The premarket notification submission must include methodology and results of the following non-clinical and clinical performance testing. For all clinical investigations used to support premarket notification submissions for this type of device, line listings of the study data must be provided. (i) Performance bench testing must demonstrate appropriate perirectal space creation and maintenance for the duration of prostate radiotherapy. (ii) Performance bench testing must demonstrate that therapeutic radiation levels do not alter the performance of the device. (iii) Performance in vivo testing must demonstrate appropriate deployment of spacer as indicated in the accompanying labeling, and demonstrate appropriate expansion and absorption characteristics in a clinically relevant environment. (iv) Clinical study must demonstrate appropriate spacer stability and lack of migration for the entire course of radiotherapy, complete absorption, and lack of long term toxicity. (v) Sterility testing must demonstrate the sterility of the device and the effects of the sterilization process on the physical characteristics of the spacer. (vi) Shelf-life testing must demonstrate the stability of the physical characteristics of the spacer throughout the shelf-life as indicated in the accompanying labeling. (vii) The device must be demonstrated to be biocompatible. (2) The risk management activities performed as part of the manufacturer's § 820.10(c) of this chapter design and development activities must document an appropriate end user initial training program which will be offered as part of efforts to mitigate the risk of failure to correctly operate the device, including, but not limited to, documentation of an appropriate end user initial training program on the proper spacer deployment technique. (3) The device labeling must include the following: (i) A detailed summary of reported or observed complications related to the use of the device; (ii) Appropriate warnings; (iii) Detailed instructions for system preparations and detailed implant procedure instructions; and (iv) An expiration date that is supported by performance data as specified in paragraph (b)(1)(vi) of this section. [83 FR 601, Jan. 5, 2018, as amended at 90 FR 55996, Dec. 4, 2025] § 892.5727 Phase-changing fiducial marker for radiation therapy. (a) Identification. (b) Classification. (1) Clinical performance data under anticipated conditions of use must evaluate: (i) Risk of marker migration in tissue during the course of radiation therapy through post-treatment follow-up; (ii) The ability to visualize the marker to allow for adequate localization during the course of radiation therapy through post-treatment follow-up; (iii) Risk of device interference with tumor response assessment post-treatment; and (iv) All adverse events. (2) Animal performance data under anticipated conditions of use must evaluate device toxicity and the risk of marker migration. (3) Non-clinical performance data under anticipated conditions of use must evaluate: (i) Maintenance of physical form throughout the course of therapy and post-treatment follow-up; (ii) Device visibility on one or more radiologic imaging modalities; and (iii) Device interference with radiation dose delivery. (4) Performance testing must demonstrate the patient-contacting components of the device are biocompatible. (5) Performance testing must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the labeled shelf life. (6) Performance testing must demonstrate device sterility and non-pyrogenicity. (7) Usability testing must demonstrate that the device can be positioned as indicated based solely on reading the directions for use. (8) The labeling must include: (i) A detailed description of the device including materials and composition, chemical and physical properties, a description of the mechanism of the change of phase, and timeframe for achieving final state; (ii) Summary of all reported device-related adverse events from clinical testing; (iii) Information describing the injection procedure, including any use of image guidance, and the range of compatible injection needle gauges; and (iv) A shelf life. [91 FR 47790, July 29, 2026] § 892.5730 Radionuclide brachytherapy source. (a) Identification. (b) Classification. [48 FR 53047, Nov. 23, 1983, as amended at 84 FR 71819, Dec. 30, 2019] § 892.5735 Vaginal hydrogel packing system. (a) Identification. (b) Classification. (1) Clinical performance data must demonstrate the device performs as intended under anticipated conditions of use and evaluate the following: (i) Radiation dose to adjacent organs at risk; (ii) Device stability; (iii) Ability to deploy, expand, and remove the device; and (iv) Patient comfort. (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Testing must include: (i) Testing to evaluate the effect of therapeutic radiation levels on device integrity; (ii) Bioburden testing to demonstrate the device does not pose an infection risk, if the device is not provided sterile; and (iii) Structural integrity testing of the container, including tensile strength, container leakage, and burst strength. (3) Performance testing must demonstrate space creation and maintenance for the duration of a radiation treatment fraction. (4) The patient-contacting components of the device must be demonstrated to be biocompatible. (5) Performance data must demonstrate the sterility of patient-contacting components of the device that are provided sterile. (6) Performance data must support the shelf life of the device by demonstrating package integrity and device functionality over the labeled shelf life. (7) Labeling must include: (i) Warnings that: (A) A three-dimensional imaging method is needed to ensure the device is placed correctly; and (B) Failure to perform the standard imaging position verification protocol may cause the device to not perform as intended. (ii) Instructions on how to proceed if the device fails to perform as intended; (iii) A summary of clinical data relevant to the device, including device-related complications; and (iv) An expiration date or shelf life. [91 FR 57510, Sept. 10, 2026] § 892.5740 Radionuclide teletherapy source. (a) Identification. (b) Classification. [53 FR 1567, Jan. 20, 1988, as amended at 59 FR 63015, Dec. 7, 1994; 66 FR 38819, July 25, 2001] § 892.5750 Radionuclide radiation therapy system. (a) Identification. (b) Classification. § 892.5770 Powered radiation therapy patient support assembly. (a) Identification. (b) Classification. § 892.5780 Light beam patient position indicator. (a) Identification. (b) Classification. [53 FR 1567, Jan. 20, 1988, as amended at 61 FR 1125, Jan. 16, 1996; 66 FR 38819, July 25, 2001] § 892.5785 Radiation therapy marking device. (a) Identification. (b) Classification. (1) Design verification and validation must include: (i) Documentation of performance data from studies that demonstrate: (A) The indicated colorant is compatible with the device and its method of delivery; (B) The device can reproducibly deliver the indicated colorant with the specifications described; and (C) The length of time that compatible colorants remain visible on the skin following device application. (ii) Documentation of performance data from studies that demonstrate: (A) Accuracy and reproducibility of needle penetration depth; (B) Device protection from cross-contamination, including fluid ingress protection; (C) Adequacy of the cleaning and disinfection instructions to ensure that the reusable components of the device can be cleaned and disinfected; and (D) The sterility of all patient-contacting components ( e.g., (iii) Documentation of performance data from studies that demonstrate electrical safety and electromagnetic compatibility of all electrical components of the device. (iv) Documentation of performance data from studies that demonstrate continued sterility, package integrity, and device functionality over the intended shelf life. (v) Documentation of software verification, validation, and hazard analysis. (2) The labeling required under § 801.109(c) of this chapter must include: (i) An explanation of the device and the mechanism of operation; (ii) Validated methods and instructions for reprocessing of any reusable components; (iii) Disposal instructions; and (iv) A shelf life for all sterile components. [91 FR 23167, Apr. 30, 2026] § 892.5840 Radiation therapy simulation system. (a) Identification. (b) Classification. § 892.5900 X-ray radiation therapy system. (a) Identification. (b) Classification. § 892.5930 Therapeutic x-ray tube housing assembly. (a) Identification. (b) Classification. Subpart G—Miscellaneous Devices § 892.6500 Personnel protective shield. (a) Identification. (b) Classification. [53 FR 1567, Jan. 20, 1988, as amended at 61 FR 1125, Jan. 16, 1996; 65 FR 2323, Jan. 14, 2000] § 892.6510 Cream for x-ray attenuation. (a) Identification. (b) Classification. (1) Design verification and validation must include documentation of results from safety and effectiveness testing. The results from safety and effectiveness testing must include: (i) Biocompatibility data consistent with the intended use for the device; (ii) Sterilization, packaging, and expiration date testing; and (iii) Nonclinical and/or clinical performance testing representative of “as use” conditions demonstrating: (A) Compatibility to the type(s) of surgical glove ( e.g., (B) Attenuation performance; and (C) Proper application of the device. (2) Labeling must include: (i) A statement that the device is sterile and an expiration date. (ii) A boxed warning statement prominently placed in all labeling material for these devices. That boxed warning statement must read: “The device is not intended to be used in or adjacent to the primary X-ray beam or transmitted beam and should not be used in lieu of a Radiographic Procedure Glove, which is used in radiography for those studies requiring the physician's hand or forearm be in the direct path of the primary X-ray beam.” (iii) The methods and results from nonclinical and/or clinical performance testing representative of “as use” conditions demonstrating the amount of attenuation the device provides to the end user at 60, 80, 100, and 120 kVp. (iv) Validated instructions for use for device application and a statement of how often the device must be removed and reapplied for effective shielding. (v) Identification of the type(s) of surgical glove ( e.g., [90 FR 27238, June 26, 2025]