The FDA has scheduled a public meeting for April 7 to discuss the the medical device user fee program that will be in place from 2022 to 2026.
The current Medical Device User Fee Amendment (MDUFA IV) expires Sept. 30, 2022. Before Congress can reauthorize the amendment, the FDA must consult with the regulated industry and make recommendations to lawmakers about its goals for the process of reviewing device applications.
The agency also uses the MDUFA to set fees for 510(k) submissions, premarket approval and device biologics license applications, 513(g) requests for information and de novo requests.
The public meeting will be held on April 7, 2020, from 9 a.m. to 5 p.m. EST. at the agency’s White Oak Campus in Silver Spring, Md. The public may also submit either electronic or written comments on the medical device user fee program and suggestions regarding the commitments FDA should propose for the next reauthorized program by May 6, 2020.
More information is available here.
