ARTICLE SUMMARY:
510(k) submissions will be notably more expensive next year under a recently hatched MDUFA V user fee agreement. The 510(k) user fee rate will increase by a 50% margin in FY 2023 compared to the current rate, and then step up more gradually over the next five years, according to Market Pathways’ review of draft legislative language. The PMA fee rate will go up by about 13% next year.
Device companies will have to pay more in fees to cover the costs of the MDUFA V user fee framework that was recently agreed to by FDA and industry trade groups. And the biggest proportional fee jump in the first year of the program will be for the most common type of submission: 510(k)s.
