Part 1 – What is MDUFA and Why Should You Care?
If you are a small medical device business (with gross receipts less than $100M USD), you should consider participating in the FDA’s Small Business Qualification and Certification program for substantial discounts on MDUFA fees. The filing period is short (August 1 – September 30) and you must register each year. Learn more about MDUFA in our posts this month and get the details on qualification and certification in the program page.
MDUFA is the abbreviation for Medical Device User Fee Amendments, a series of Acts passed by the US Congress to increase the FDA resources for the review of medical devices. Before the first Act in 2002, the agency’s long-term resource deficits meant lengthy delays for reviews and out of date guidance documents. Expedited reviews were taking longer than standard reviews. Industry leaders approached Congress about supplementing increased appropriations with new user fees. With the help of the FDA and industry, Congress passed the Medical Device User Fee Modernization Act in 2002. The Act has four parts:
- Set user fees for medical device premarket applications,
- Created performance goals for premarket application review,
- Allowed accredited persons to conduct establishment inspections, and
- Established new requirements for reprocessed single-use devices.
The amendments were reauthorized and updated in 2007 (MDUFA II), 2012 (MDUFA III), and 2017 (MDUFA IV). The MDUFA page shows the current year’s fees. You will note the substantial difference between the standard and small business fees; we’ll discuss this in the next post. Since MDUFA implementation, the review process is more streamlined, and the FDA consistently meets the performance targets for review timelines, infrastructure changes, and process improvements (we’ll discuss this further in another post). The review timelines enable a business to plan post-approval manufacturing and marketing activities.
Reach out to me if you want to know more or discuss your medical product development challenges.
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Text Copyright © 2020 Katrina Rogers
Image from the FDA web site