FDA Public Event (Virtual): Medical Device User Fee Amendments 2023-2027

October 27, 2020
9:00 a.m. - 2:00 p.m.

Virtual Public Meeting - Medical Device User Fee Amendments for Fiscal Years 2023 Through 2027
October 27, 2020
9:00 a.m. - 2:00 p.m.
Register at:  https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/virtual-public-meeting-medical-device-user-fee-amendments-fiscal-years-2023-through-2027-10272020?utm_medium=email&utm_source=govdelivery#registration

The U.S. Food and Drug Administration (FDA) is announcing a public meeting on the reauthorization of the Medical Device User Fee Amendments for fiscal years 2023 through 2027 (MDUFA V). The current legislative authority for the medical device user fee program expires on September 30, 2022. New legislation is required for the FDA to continue to collect user fees for the medical device program in future fiscal years.

The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that before the FDA begins negotiations with the regulated industry on MDUFA reauthorization, we must take the following steps:

  • Publish a notice in the Federal Register requesting public input on the reauthorization,
  • Hold a public meeting at which the public may present its views on the reauthorization,
  • Provide a period of 30 days after the public meeting to obtain written comments from the public suggesting changes to MDUFA, and
  • Publish the comments on the FDA’s website. 

Federal Register Notice:  https://www.federalregister.gov/documents/2020/09/08/2020-19771/medical-device-user-fee-amendments-for-fiscal-years-2023-through-2027-public-meeting-request-for

 

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