Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device Accessories

<NOTICE> DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Food and Drug Administration</SUBAGY> <DEPDOC>[Docket No. FDA-2025-P-0100]</DEPDOC> <SUBJECT>Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device Accessories</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Food and Drug Administration, HHS. <HD SOURCE="HED">ACTION:</HD> Notice. <SUM> <HD SOURCE="HED">SUMMARY:</HD> The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. </SUM> <DATES> <HD SOURCE="HED">DATES:</HD> Submit written comments (including recommendations) on the collection of information by October 3, 2025. </DATES> <HD SOURCE="HED">ADDRESSES:</HD> To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to <E T="03">https://www.reginfo.gov/public/do/PRAMain.</E> Find this particular information collection by selecting “Currently under Review—Open for Public Comments” or by using the search function. The OMB control number for this information collection is 0910-0823. Also include the FDA docket number found in brackets in the heading of this document. <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10 a.m.-12 p.m., 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867, <E T="03">PRAStaff@fda.hhs.gov.</E> </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. <HD SOURCE="HD1">Medical Device Accessories</HD> <HD SOURCE="HD2">OMB Control Number 0910-0823—Extension</HD> FDA's guidance document entitled “Medical Device Accessories—Describing Accessories and Classification Pathways” (December 2017) (available at <E T="03">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/medical-device-accessories-describing-accessories-and-classification-pathways</E> ) is intended to provide guidance to industry and FDA staff about the regulation of accessories to medical devices, to describe FDA's policy concerning the classification of accessories, and to discuss the application of this policy to devices that are commonly used as accessories to other medical devices. In addition, the guidance explains what devices FDA generally considers an “accessory” and describes the processes under section 513(f)(6) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c(f)(6)) (FD&C Act) to allow requests for risk- and regulatory control-based classification of accessories. The FDA Reauthorization Act of 2017 (FDARA) changed how FDA regulates medical device accessories. Specifically, section 707 of FDARA added section 513(f)(6) of the FD&C Act to the statute and requires that FDA, upon request, classify existing and new accessories notwithstanding the classification of any other device with which such accessory is intended to be used. This means that the classification of an accessory may not be the same as its parent device, depending on the risks of the accessory when used as intended and the level of regulatory controls necessary for reasonable assurance of safety and effectiveness of the accessory. Until an accessory is distinctly classified, its existing classification will continue to apply. This provision does not preclude a manufacturer from submitting a De Novo request for an accessory under section 513(f)(2) of the FD&C Act. Depending on an accessory's regulatory history, there are different submission types, tracking mechanisms, and deadlines: (1) Existing accessory types are those that have been identified in a classification regulation or granted marketing authorization as part of a 510(k) (section 510(k) of the FD&C Act (21 U.S.C. 360(k), premarket application (PMA) (section 515 of the FD&C Act (21 U.S.C. 360e), or De Novo (section 513(f)(2) of the FD&C Act) request (approved under OMB control numbers 0910-0120, 0910-0231, and 0910-0844, respectively). Manufacturers with marketing authorization for an existing accessory may request appropriate classification through a new stand-alone premarket submission (Existing Accessory Request). Upon request, FDA is required to meet with a manufacturer or importer to discuss the appropriate classification of an existing accessory prior to submitting a written request. Existing Accessory Requests will be initially tracked as “Q-submissions” (approved under OMB control number 0910-0756). FDA has a statutory deadline of 85 calendar days to respond to an Existing Accessory Request. (2) New accessory types are those that have not been granted marketing authorization as part of a 510(k), PMA, or De Novo request. Manufacturers may include new accessories in a 510(k) or PMA with the parent device (New Accessory Request). New Accessory Requests will have the same deadline as the 510(k) or PMA. Therefore, new accessory types should follow the applicable Medical Device User Fee Amendments of 2017 deadline for the parent submission. The decision for New Accessory Requests will be separate from the decision for the marketing application. For both Existing and New Accessory Requests, manufacturers must request proper classification of their accessory in the submission and include draft special controls, if requesting classification into class II. The processes that we use to classify an accessory will be like those used for De Novo requests. If FDA grants the Accessory Request, FDA must issue an order establishing a new classification regulation for the accessory type. If FDA denies the Accessory Request, FDA must issue a letter with a detailed description and justification for our determination. In the <E T="04">Federal Register</E> of June 16, 2025 (90 FR 25326), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. FDA estimates the burden of this collection of information as follows: <GPOTABLE COLS="6" OPTS="L2,nj,i1" CDEF="s50,11,12,9,12,6"> <TTITLE> Table 1—Estimated Annual Reporting Burden  <SU>1</SU> </TTITLE> <CHED H="1">Activity</CHED> <CHED H="1">Number of respondents</CHED> <CHED H="1"> Number of responses per respondent <ENT I="01">Existing Accessory Request</ENT>  There are no capital costs or operating and maintenance costs associated with this collection of information. </TNOTE> </GPOTABLE> Based on a review of the information collection since our last request for OMB approval, we have made no adjustments to our burden estimate. <SIG> <NAME>Grace R. Graham,</NAME> Deputy Commissioner for Policy, Legislation, and International Affairs. </SIG> </SUPLINF> <FRDOC>[FR Doc. 2025-16853 Filed 9-2-25; 8:45 am]</FRDOC> </NOTICE>