Congress recently authorized the Medical Device User Fee Amendments of 2012 (MDUFA III) as part of the FDA Safety and Innovation Act. MDUFA III will take effect on October 1, 2012 and is a 5-year agreement ending on September 30, 2017.
Device user fees, first established by Congress in 2002, are paid to the Food and Drug Administration (FDA) by medical device companies when they register and list with the FDA, and when they submit an application or notification to market a medical device in the U.S. (Other parts of the legislation renewed user fee agreements for the review of drug applications.) Ultimately, MDUFA III represents a commitment between the U.S. medical device industry and the FDA to increase the efficiency of regulatory processes in order to reduce the time it takes to bring safe and effective medical devices to the U.S. market.
MDUFA III is the result of more than a year of public input and negotiations with industry representatives and patient and consumer representatives. Under the new agreement, the FDA can collect $595 million (plus adjustments for inflation) in user fees over five years. With the additional funding, the FDA will be able to hire more than 200 full-time-equivalent workers by the time the agreement expires in five years.
In exchange, the FDA has committed to meet certain performance goals also outlined in the legislation. For example, in 2013, the FDA will issue a decision about whether or not to allow marketing for 91 percent of 510(k) submissions within 90 days.
As part of the legislation, an outside consulting firm will evaluate FDA’s pre-market review process and the agency’s progress in meeting these goals, including timely interactions with industry.
How much money does MDUFA III authorize in user fees?
MDUFA III authorizes $595 million in user fees for 2013-2017.
Are there any changes in who must pay user fees under MDUFA III?
Yes. MDUFA III expands the definition of the types of manufacturers that must pay a registration fee.
What are the medical device user fees for 2013?
The fees for 2013 are as follows (small-business fees in parentheses):
|Panel-track PMA supplements:||$186,000 ($46,500)|
|180-day supplements:||$37,200 ($9,300)|
|Real-time supplements:||$17,360 ($4,340)|
|30-day notice:||$3,968 ($1,984)|
|PMA annual report:||$8,680 ($2,170)|
|Annual establishment registration fee:||$2,575 ($2,575)|
What are FDA’s performance goals for 2013?
Specifics of FDA’s performance goals for 2013 and beyond are listed in the MDUFA Performance Goals and Procedures commitment letter.
How will the FDA implement MDUFA III?
The FDA will issue a series of guidance documents that help explain key provisions. These guidance documents include:
- Guidance for Industry and FDA Staff; Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications (issued 3/28/2012)
- Guidance for Industry and FDA Staff; Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff (issued 2/18/2014)
- Draft Guidance for Industry and FDA Staff; Refuse to Accept (510(k))
- Draft Guidance for Industry and FDA Staff; Refuse to Accept/Refuse to File ( PMA)
- Guidance for Industry and FDA Staff; Interactions During Review of Medical Device Submissions
- Guidance for Industry and FDA Staff; Actions on 510(k)s - Effect on Review Clock
- Guidance for Industry and FDA Staff; Actions on PMAs - Effect on Review Clock
- Draft Guidance for Industry and FDA Staff; eCopy
- Guidance for Industry and FDA Staff; User Fees and Refunds for 510(k)s
- Guidance for Industry and FDA Staff; User Fees and Refunds for Premarket Approval Applications