FDA medical device user fees to increase 6%

Aug. 7, 2019

Manufacturers have until September 30, 2019 to submit premarket applications to FDA and pay lower 2019 user fees.

FDA’s 2020 user fee schedule takes effect October 1, 2020, and entails six-percent increases for both standard and small-business rates. The agency’s 2020 fiscal year increases are slightly higher than for 2019, which saw four-percent increases for most user fees.

The Food and Drug Administration has announced that its medical device user fees for 510(k) premarket notifications, Premarket Approvals (PMAs) and other market registration applications will increase by about six percent for the agency’s 2020 fiscal year.

Standard 2020 FDA medical device user fees:

To qualify for substantially reduced user fees under FDA’s Small Business Program, manufacturers must have sales of less than $100 million for the most recent tax year.

The 2020 establishment registration fees are up seven percent. FDA Establishment Registration fees, applicable to manufacturers that produce all or parts of their devices within the U.S., or that conduct sterilization and other processing within the U.S., will increase by seven percent to $5,236 for the 2020 fiscal year. No small-business discounts are available for this fee.