The US FDA released the 2022 user fees for certain medical device submissions and establishment registration. On August 2, 2021, the FDA announced the FY2022 user fees in a Federal Register notice titled Medical Device User Fee Rates for Fiscal Year 2022. FY2022 User fees are required for the following types of medical device submissions:...Read More

Premarket Notifications (510(k)s), Premarket Approval Applications (PMAs), Premarket Reports (PMRs), notices, and supplements all have associated fees to be paid to the FDA before they will review a medical device product. The 2019 Medical Device User Fee Amendments (MDUFA) are listed at 2019 MDUFA. If the FDA determines that a manufacturer is a “small business”...Read More

Also states the new annual registration fees. Keep in mind, businesses with gross revenue under USD $100 million qualify for the reduced small business fees listed.Read More