Dive Brief:
- FDA published a notice Tuesday detailing its rates and payment procedures for medical device user fees in fiscal year 2020, effective Oct. 1, 2019, through Sept. 30, 2020. The fees are tied to medical device submissions, establishment registration and certain periodic reports.
- Base fees for premarket applications and establishment registrations are up by $10,000 and about $200, respectively, compared to 2019.
- The agency advises paying the application fee either before making a device submission or at the time of the submission to avoid a delay in its review.
Dive Insight:
Under the user fee system, medical device companies make payments to FDA when they register their establishments, list devices with the agency, submit an application or a notification to market a new medical device in the United States, and for certain other submissions.
FDA said the base fee for a premarket application received during fiscal 2020 is $310,000, an increase of $10,000 from 2019. The base fee is a starting point for calculating 2020 fee rates for certain types of submissions and for periodic reporting based on an established set of criteria.
The base fee for an establishment registration in 2020 is $4,760, up from $4,548 in 2019. The total revenue amount for 2020 is $200.1 million, up from $190.7 million. All are subject to inflation adjustments.
Small businesses can qualify for reduced fees by submitting a small business certification request before making a device submission to FDA. The establishment registration fee is not eligible for a reduced small business fee.
Device user fees were first established in 2002 by the Medical Device User Fee and Modernization Act (MDUFMA). User fees were renewed in 2007, in 2012, and in 2017 with the Medical Device User Fee Amendments to the FDA Reauthorization Act (MDUFA IV). MDUFA IV will be in place from Oct. 1, 2017, until Sept. 30, 2022.
