FDA Continues to Make Progression in MDUFA Negotiations

November 11, 2015

FDA Center for Devices and Radiological Health - CDRH

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.

Reauthorization Meetings

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

  • In response to Industry’s data request, FDA presented the results of an analysis conducted on pre-submissions for IDEs, announcing its finding that IDEs with pre-submissions have a greater likelihood of first cycle approval.
  • During the September 9th meeting, Industry also requested additional information regarding the number of guidance documents published by CDRH. During this meeting FDA provided a summary of all relevant guidance documents that have been issued during MDUFA III. “The summary included the numbers of guidance documents that were revisions to existing guidance documents, guidance on special controls, guidance documents mandated by legislation, or other CDRH initiatives.”

Reviewed CDRH information systems for premarket reviews

  • FDA provided a summary of the CDRH premarket IT systems. This information further explained the data that is available and the capabilities and limitations of the CDRH systems in support of premarket reviews. The Agency noted that premarket systems are designed to focus on tracking necessary information for the management and reporting of MDUFA performance commitments. FDA noted where the systems require manual data entry, which data fields are validated, and how information is transferred between systems.

Implementation of the Independent assessment

  • FDA summarized CDRH’s implementation of the Center’s Plan of Action to address the recommendations in Booz Allen Hamilton’s MDUFA II/III Evaluation. The Agency provided a progress summary of 11 recommendations designed to improve the efficiency and review times of the medical device submission review process. The 11 recommendations fall into five categories, including:
  1. Quality Management
  2. Evaluation of Review Process
  3. Evaluation of IT Infrastructure and Workload Tools
  4. Evaluation of Training Programs
  5. Assessment of Staff Turnover
  • FDA’s minutes from the meeting stated that “FDA shared progress on each of the recommendations and discussed the procedures and improvements CDRH has implemented. CDRH has completed Stage 1 for seven of the eleven recommendations, including all four projects under the Quality Management recommendation. FDA projects that all Stage 1 actions will be met by December 2015. Resources permitting, CDRH will continue to implement Stage 2 actions.”

Additional financial analysis

  • FDA presented additional financial analysis, which included a description of the medical device program resource environment, carryover balances, and one-time costs and efficiencies.

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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