Dive Brief:
- FDA announced rates and payment procedures for medical device user fees for fiscal year 2019. The rates apply from Oct. 1, 2018 through Sept. 30, 2019.
- The user fees cover medical device submissions as well as annual fees for certain periodic reports and for establishments subject to registration.
- Small businesses can qualify to pay a reduced fee, rather than the standard fee, by submitting a small business certification request.
Dive Insight:
FDA said the base fee for a premarket application received during fiscal 2019 is $300,000. The base fee for an establishment registration is $4,548. The total revenue amount for 2019 is $190.7 million. All are subject to inflation adjustments.
FDA user fees increased across all registration categories in fiscal 2018.
Under the user fee system, medical device companies pay FDA when they register their establishments and list their devices with the agency, whenever they submit an application or a notification to market a new medical device, and for certain other types of submissions.
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.
FDA said its goal in collecting the fees is to reduce the time it takes to bring safe and effective medical devices to the U.S. market.
