Small Business: This is defined as having gross receipts or sales of no more than $100 million for the most recent tax year.
FY19 User Fees for Medical Device Submissions The following table identifies the FY19 User Fees for Medical Device Submissions (in U.S. dollars).
Small Business Fee†
PMA, PDP, PMR, BLA
De Novo classification request
BLA efficacy supplement
† For small businesses with an approved SBD. ‡ Note: All types of 510(k)s (Traditional, Abbreviated, and Special) are subject to the user fee. However, there is no user fee for 510(k)s submitted by an FDA-accredited Third- Party Reviewer to the FDA.