Microbiology Devices; Reclassification of Antigen, Antibody, and Nucleic Acid-Based Hepatitis B Virus Assay Devices

<RULE> DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Food and Drug Administration</SUBAGY> <CFR>21 CFR Part 866</CFR> <DEPDOC>[Docket No. FDA-2024-N-3533]</DEPDOC> <SUBJECT>Microbiology Devices; Reclassification of Antigen, Antibody, and Nucleic Acid-Based Hepatitis B Virus Assay Devices</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Food and Drug Administration, Department of Health and Human Services (HHS). <HD SOURCE="HED">ACTION:</HD> Final amendment; final order. <SUM> <HD SOURCE="HED">SUMMARY:</HD> The Food and Drug Administration (FDA) is issuing a final order reclassifying qualitative hepatitis B virus (HBV) antigen assays (product code LOM), HBV antibody assays (product code LOM), and quantitative HBV nucleic acid-based assays (product code MKT), all of which are postamendments class III devices, into class II (special controls), subject to premarket notification. FDA is also establishing the special controls that are necessary to provide a reasonable assurance of safety and effectiveness of these device types. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> This order is effective October 20, 2025. See further discussion in Section IV, “Implementation Strategy.” </EFFDATE> <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> Bhawna Poonia, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3226, Silver Spring, MD 20993, 240-402-6830, <E T="03">bhawna.poonia@fda.hhs.gov.</E> </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">I. Background—Regulatory Authorities</HD> The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended, establishes a comprehensive system for the regulation of medical devices intended for human use. Section 513 of the FD&C Act (21 U.S.C. 360c) established three classes of devices, reflecting the regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three classes of devices are class I (general controls), class II (special controls), and class III (premarket approval). Devices that were not in commercial distribution prior to May 28, 1976 (generally referred to as postamendments devices) are automatically classified by section 513(f)(1) of the FD&C Act into class III without any action taken by FDA (or the Agency). Those devices remain in class III and require premarket approval, unless and until: (1) FDA reclassifies the device into class I or II; or (2) FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of the FD&C Act, to a predicate device that does not require premarket approval. The Agency determines whether new devices are substantially equivalent to previously marketed devices by means of the procedures in section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and our implementing regulations (part 807, subpart E (21 CFR part 807, subpart E)). A postamendments device that has been initially classified into class III under section 513(f)(1) of the FD&C Act may be reclassified into class I or class II under section 513(f)(3) of the FD&C Act. Section 513(f)(3) provides that FDA, acting by administrative order, can reclassify the device into class I or class II on its own initiative, or in response to a petition from the manufacturer or importer of the device. To change the classification of the device, the new class must have sufficient regulatory controls to provide reasonable assurance of the safety and effectiveness of the device for its intended use. <SU>1</SU> <FTREF/> <FTNT> <SU>1</SU>  See section 513 of the FD&C Act. </FTNT> FDA relies upon “valid scientific evidence,” as defined in section 513(a)(3) of the FD&C Act and 21 CFR 860.7(c)(2), in the classification process to determine the level of regulation for devices. <SU>2</SU> <FTREF/> In general, to be considered in the reclassification process, the “valid scientific evidence” upon which the Agency relies must be publicly available. Publicly available information excludes trade secret and/or confidential commercial information, <E T="03">e.g.,</E> the contents of a pending PMA (see section 520(c) of the FD&C Act (21 U.S.C. 360j(c))). <FTNT> <SU>2</SU>   <E T="03">Id.</E> </FTNT> Section 510(m) of the FD&C Act provides that FDA may exempt a class II device from the requirements under section 510(k) of the FD&C Act if FDA determines that a premarket notification (510(k)) is not necessary to provide reasonable assurance of the safety and effectiveness of the device type. On September 25, 2024, FDA published a proposed order  <SU>3</SU> <FTREF/> in the <E T="04">Federal Register</E> to reclassify qualitative HBV antigen assays (product code LOM), <SU>4</SU> <FTREF/> qualitative HBV antibody assays and quantitative assays that detect anti-HBs (antibodies to HBV surface antigen (HBsAg)) (product code LOM), <SU>5</SU> <FTREF/> and quantitative HBV nucleic acid-based assays (product code MKT) from class III to class II (89 FR 78265, the “proposed order”). <SU>6</SU> <FTREF/> FDA has considered the information available to the Agency, including the deliberations of the Microbiology Devices Panel (the “Panel”) convened on September 7, 2023, to discuss the proposed reclassification of these devices, and considered comments for that meeting as well as comments received from the public docket on the proposed order (as discussed in Section II of this document), to determine that there is sufficient information to establish special controls to effectively mitigate the risks to health. FDA has also determined that based on this information that the special controls, together with general controls, provide a reasonable assurance of safety and effectiveness when applied to these devices. <FTNT> <SU>3</SU>  The “ACTION” caption for this proposed order was styled as “Proposed amendment; proposed order; request for comments” rather than “Proposed order.” Beginning in December 2019, this editorial change was made to indicate that the document “amends” the Code of Federal Regulations. The change was made in accordance with the Office of the Federal Register's (OFR) interpretations of the <E T="04">Federal Register</E> Act (44 U.S.C. chapter 15), its implementing regulations (1 CFR 5.9 and parts 21 and 22), and the Document Drafting Handbook. </FTNT> <FTNT> <SU>4</SU>  FDA's Center for Devices and Radiological Health (CDRH) uses product codes to help categorize and ensure consistent regulation of medical devices. A product code consists of three characters that are assigned at the time a product code is generated and is unique to a product type. The three characters carry no other significance and are not an abbreviation. See FDA guidance entitled, “Medical Device Classification Product Codes” available at <E T="03">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/medical-device-classification-product-codes-guidance-industry-and-food-and-drug-administration-staff.</E> </FTNT> <FTNT> <SU>5</SU>  These devices are currently regulated under product code LOM, but upon the finalization of this action they will fall within the newly created product code SEI. </FTNT> <FTNT> <SU>6</SU>  In the proposed order, FDA proposed to reclassify “Hepatitis B virus antibody assays (including qualitative and quantitative anti-HBs)” under the classification regulation 21 CFR 866.3179. In this final order, FDA is simplifying the identification of the classification regulation name to “Hepatitis B virus antibody assays” and adding further description to the identification language to better describe the devices that fit within this generic device type and are subject to this reclassification order. In addition, in the proposed order, FDA proposed to reclassify qualitative hepatitis B virus antigen assays under new classification regulation 21 CFR 866.3178 and quantitative hepatitis B virus nucleic acid-based assays under new classification regulation 21 CFR 866.3180. However, at the time of publication of this final order, a different regulation has been codified at § 866.3180. Therefore, in this final order, FDA is reclassifying these device types under different sections of the Code of Federal Regulations than was proposed in the proposed order. Specifically, FDA is reclassifying qualitative hepatitis B virus antigen assays under new classification regulation 21 CFR 866.3172, hepatitis B virus antibody assays under new classification regulation 21 CFR 866.3173, and hepatitis B virus nucleic acid-based assays under new classification regulation 21 CFR 866.3174. </FTNT> Therefore, in accordance with section 513(f)(3) of the FD&C Act, FDA, on its own initiative, is issuing this final order  <SU>7</SU> <FTREF/> to reclassify qualitative HBV antigen assays, HBV antibody assays, and quantitative HBV nucleic acid-based assays  <SU>8</SU> <FTREF/> from class III (premarket approval) to class II (special controls). Absent the special controls identified in this final order, general controls applicable to these device types are insufficient to provide reasonable assurance of the safety and effectiveness of these devices. FDA expects that the reclassification of these devices will enable more manufacturers to develop these types of devices such that patients will benefit from increased access to safe and effective diagnostics. <FTNT> <SU>7</SU>  FDA notes that the “ACTION” caption for this final order is styled as “Final amendment; final order,” rather than “Final order.” Beginning in December 2019, this editorial change was made to indicate that the document “amends” the Code of Federal Regulations. The change was made in accordance with the Office of Federal Register's (OFR) interpretations of the Federal Register Act (44 U.S.C. chapter 15), its implementing regulations (1 CFR 5.9 an ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 70k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━