November 11, 2015
In 2002, the Medical Device User Fee and Modernization Act (MDUFMA) was passed, which introduced the first user fees for medical devices. MDUFMA established a system which would require medical device companies to pay fees to FDA for various activities relating to their products. These fees were implemented to help increase the efficiency of the regulatory process by reducing FDA review times and, hopefully, bringing safe and effective medical devices to the market in a more timely manner.
Similar to all other user fees (e.g. user fees established under PDUFA), the fees established by MDUFMA are subject to reauthorization every five years. Accordingly, medical device user fees were renewed in 2007 with the Medical Device User Fee Amendments to the FDA Amendments Act (MDUFA II), and again in 2012 with the Medical Device User Fee Amendments to the FDA Safety and Innovation Act (MDUFA III). In 2017, the medical device user fee program (MDUFA IV) will be re-authorized for the fourth time since its implementation, and in July 2015, FDA kicked off the reauthorization negotiations by holding a public meeting on the subject.
On September 9, 2015, FDA’s held its first Industry MDUFA IV reauthorization meeting. FDA invited all national associations that the Agency believes best represent medical device manufacturers who may be subject to fees under the negotiated agreement to attend the meeting. Most of the discussion revolved around introductory commentary and housekeeping matters. FDA and Industry discussed and agreed upon ground rules that will govern the MDUFA IV reauthorization negotiations.
During this meeting, FDA expressed its perspective on the reauthorization, stating that it is committed “to achieving the goal of patient access to high-quality, safe, and effective medical devices.” Industry participants also shared their perspective, reiterating “their shared commitment to the goal of timely access to safe and effective medical devices. Each association discussed its goals for reauthorization and, in general, noted improvements to the premarket review program over the past few years under the MDUFA III agreement and their desire to identify targeted areas for enhancements for MDUFA IV.”
On October 1, 2015, FDA held the second Industry MDUFA IV reauthorization meeting. In this meeting various topics were discussed between FDA and Industry, including:
FDA’s response to Industry’s data request
Reviewed CDRH information systems for premarket reviews
Implementation of the Independent assessment
Additional financial analysis
The meeting was concluded with an agreement between FDA and Industry to determine the schedule for negotiation meetings in 2016. FDA agreed to elaborate on the 510(k) and de novo programs prior to the next meeting, and FDA and Industry discussed the agenda for the next negotiation meeting.
The next meeting will be held on November 18, 2015, at which time both parties expect to be ready to present their respective proposals.
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