![FDA, FTC and DOJ Enforcement of Medical Device Regulations FDA, FTC and DOJ Enforcement of Medical Device Regulations](https://www.fdanews.com/ext/resources/Book-Covers-2/BFFDEMDR-COVER.png?height=200&t=1685733565&width=200)
Home » FDA: Request Small Business Status Before Sending FY 2017 Applications
FDA: Request Small Business Status Before Sending FY 2017 Applications
![](https://www.fdanews.com/ext/resources/test/Device_Images4/FDA_Logo_Large.gif?t=1486528488&width=430)
Devicemakers seeking small business status for fiscal year 2017 should apply before submitting any product applications, a new FDA guidance advises.
Businesses with gross receipts or sales of $100 million or less for the most recent tax year qualify for a “significant reduction” in user fees, the FDA said. Those with $30 million or less qualify for a one-time waiver of the fee for their first-ever PMA application, BLA application, product development protocol or premarket report.
For fiscal 2017, the Premarket Application (PMA, BLA, PDP) fee for standard businesses is $234,495 while small businesses pay $58,624. The establishment registration fee remains the same for both small businesses and standard businesses. — April Hollis
Upcoming Events
-
11Jul
-
18Jul
-
21Oct