Reauthorization of the Medical Device User Fee Amendments; Public Meeting; Request for Comments

<NOTICE> DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Food and Drug Administration</SUBAGY> <DEPDOC>[Docket No. FDA-2025-N-1157]</DEPDOC> <SUBJECT>Reauthorization of the Medical Device User Fee Amendments; Public Meeting; Request for Comments</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Food and Drug Administration, HHS. <HD SOURCE="HED">ACTION:</HD> Notice of public meeting; request for comments. <SUM> <HD SOURCE="HED">SUMMARY:</HD> The Food and Drug Administration (FDA, the Agency, or we) is hosting a hybrid public meeting entitled “Medical Device User Fee Amendments.” The purpose of the public meeting is to discuss proposed recommendations for the reauthorization of the Medical Device User Fee Amendments (MDUFA) for fiscal years (FYs) 2028 through 2032. MDUFA authorizes FDA to collect fees and use them for the process for the review of device applications. The current legislative authority for MDUFA expires September 30, 2027. At that time, new legislation will be required for FDA to continue collecting device user fees in future fiscal years. The Federal Food, Drug, and Cosmetic Act (FD&C Act) directs that FDA begin reauthorization by publishing a notice in the <E T="04">Federal Register</E> requesting public input and holding a meeting where the public may present its views on the reauthorization. FDA invites public comment as the Agency begins the process to reauthorize the program in FYs 2028 through 2032. These comments will be published and available on FDA's website. </SUM> <DATES> <HD SOURCE="HED">DATES:</HD> The public meeting will be held on August 4, 2025, from 10 a.m. to 3 p.m. Eastern Time and will take place in-person with a webcast option. Submit electronic or written comments on this public meeting by September 4, 2025. See the <E T="02">SUPPLEMENTARY INFORMATION</E> section for registration date and information. </DATES> <HD SOURCE="HED">ADDRESSES:</HD> The public meeting will be held in-person at the FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the White Oak Great Room, Silver Spring, MD 20993-0002 and virtually using the Microsoft Teams platform. Entrance for the public meeting participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. Participants must be REAL ID compliant to access federal facilities. For additional information regarding REAL ID, refer to <E T="03">https://www.dhs.gov/real-id/real-id-faqs.</E> For security and parking information, please refer to <E T="03">https://www.fda.gov/about-fda/visitor-information/public-meeting-information</E> and <E T="03">https://www.fda.gov/about-fda/visitor-information/visitor-parking-and-campus-map.</E> You may submit comments as follows. Please note that late, untimely filed comments will not be considered. The <E T="03">https://www.regulations.gov</E> electronic filing system will accept comments until 11:59 p.m. Eastern Time on September 4, 2025. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received on or before that date. <HD SOURCE="HD2">Electronic Submissions</HD> Submit electronic comments in the following way: • <E T="03">Federal eRulemaking Portal: https://www.regulations.gov.</E> Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to <E T="03">https://www.regulations.gov</E> will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on <E T="03">https://www.regulations.gov.</E> • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”). <HD SOURCE="HD2">Written/Paper Submissions</HD> Submit written/paper submissions as follows: • <E T="03">Mail/Hand Delivery/Courier (for written/paper submissions):</E> Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.” <E T="03">Instructions:</E> All submissions received must include the Docket No. FDA-2025-N-1157 for “Reauthorization of the Medical Device User Fee Amendments; Public Meeting; Request for Comments.” Received comments, those filed in a timely manner (see <E T="02">ADDRESSES</E> ), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at <E T="03">https://www.regulations.gov</E> or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on <E T="03">https://www.regulations.gov.</E> Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: <E T="03">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.</E> <E T="03">Docket:</E> For access to the docket to read background documents or the electronic and written/paper comments received, go to <E T="03">https://www.regulations.gov</E> and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500. <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> Nia Benjamin, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Room 5422, Silver Spring, MD 20993-0002, 301-796-5424, <E T="03">MDUFAVIReauthorization@fda.hhs.gov.</E> </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">I. Background</HD> FDA is announcing a hybrid public meeting to begin the reauthorization process for MDUFA, the legislation that authorizes FDA to collect user fees to support the process for the review of medical device applications, which reaches various components in FDA, including the Center for Devices and Radiological Health (CDRH), the Center for Biologics Evaluation and Research (CBER), the Office of the Commissioner (OC), and the Office of Inspections and Investigations (OII). The current authorization of the program (MDUFA V) expires September 30, 2027. Section 738A(b)(2) of the FD&C Act (21 U.S.C. 379j-1(b)(2)) requires that, before FDA begins negotiations with regulated industry on MDUFA reauthorization, the Agency performs the following: (1) publish a notice in the <E T="04">Federal Register</E> requesting public input on the reauthorization; (2) hold a public meeting where the public may present its views on the reauthorization; (3) provide a period of 30 days after the public meeting to obtain written comments from the public; and (4) publish the comments on FDA's website. This notice, the public meeting, the 30-day comment period after the meeting, and the posting of the comments on the FDA's website will satisfy these requirements. The purpose of the meeting is to hear stakeholder views on MDUFA as we consider the features to propose, update, discontinue, or add in the next MDUFA. FDA is interested in responses to the following questions and welcomes any other pertinent information stakeholders would like to share: (1) What is your assessment of the overall performance of MDUFA V thus far? (2) What current features of MDUFA should be reduced or discontinued to ensure the continued efficiency and effectiveness of the medical device review process? (3) What new features should FDA consider adding to the program to enhance the efficiency and effectiveness of the medical devices review process? (4) What changes, if any, could be made to the current fee structures and amounts to better advance the goals of the agreement, including facilitating product development and timely access for consumers? <HD SOURCE="HD1">II. Public Meeting Information</HD> <HD SOURCE="HD2">A. Purpose and Scope of the Meeting</HD> In general, the public meeting's format will include presentations by FDA and other interested parties, wh ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 14k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━