The FDA is hosting a public meeting titled “Medical Device User Fee Amendments” on Wednesday, November 2, from 9 a.m. to 5 p.m. EST at its Silver Spring, Md., location. The purpose of the meeting is to discuss proposed recommendations for the reauthorization of the Medical Device User Fee Amendments (MDUFA) for fiscal years 2018 through 2022.
MDUFA authorizes the FDA to collect fees and use them for the process of reviewing medical device applications. The current legislative authority for MDUFA expires Oct. 1, 2017. At that time, new legislation will be required for the FDA to continue collecting medical device user fees in future fiscal years.
Following discussions with the device industry and periodic consultations with public stakeholders, the Federal Food, Drug, and Cosmetic Act directs the FDA to publish the draft recommendations for the reauthorized program in the Federal Register, hold a meeting at which the public may present its views on such draft recommendations, and provide for a period of 30 days for the public to submit written comments on such draft recommendations. The FDA will then consider such public views and comments and revise recommendations as necessary.
The November 2 meeting will be captured via webcast, and a link to the webcast with be published on the FDA’s website after Wednesday, October, 26. Registration is not required to view the webcast.
Industry professionals wanting to attend the public meeting in person, however, must register by 4:00 p.m. EST on October 26. There is no fee to register for the public meeting, and registration will be on a first-come, first-served basis. Even so, early registration is recommended since seating is limited.
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