This week FDA released the new figures for medical device user fees, annual establishment registration fees, and small business designation and fees for FY 2019 (October 1, 2018–September 30, 2019). The notice was posted on the Federal Register on July 30.
User fees, which will increase about 4%, go into effect on October 1. The agency requires user fees for many types of medical device submissions, including PMAs, 510(k)s, premarket reports, product development protocols (PDPs), premarket reports, annual reports for PMAs, PDPs, and PMRs, and De Novo classification requests. The fees are reduced for qualified small businesses, which fall into the category of $100 million or less in gross receipts or sales. If a business has gross receipts or sales of $30 million or less, the company is eligible for a fee waiver for its first PMA, PDP, PMR or biologics license application.
|FY 2019 User Fees for Medical Device Submissions
|Application Type||Standard Fee ($ U.S.)||Small Business Fee ($ U.S.)|
|PMA, PDP, PMR, BLA||322,147||80,537|
|De Novo classification request||96,644||24,161|
|BLA efficacy supplement||322,147||80,537|
All companies, regardless of size, must pay the annual establishment registration fee, which is $4,884 for FY 2019.