Here's what the proposed Medical Device User Fee Amendments IV, slated to take effect in October 2017, mean for the device industry.
Heather Rosecrans, FRAPS
The Medical Device User Fee and Modernization Act (MDUFMA) in 2002 marked the beginning of the user fee program for devices in the U.S. The additional resources provided to FDA's CDRH since the time of program enactment have enabled CDRH to stabilize, and subsequently significantly increase the Center's staffing level, upgrade IT capabilities, and develop a number of process enhancements.
Since the creation of MDUFMA, FDA and its stakeholders (industry and later on including patient advocacy groups) have worked through growing pains to identify and develop more meaningful device performance goals and commitments. Overall, the progress made through MDUFMA and its amendments, MDUFA II and MDUFA III, has certainly provided the Center with the tools needed to develop a level of predictability, consistency, and transparency of FDA medical device processes desired by all stakeholders. Most importantly, these commitments should lead to improved access to safe and effective devices for the public!
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Over the last year, FDA and its stakeholders have again come together to discuss what worked well to date and what could be improved upon in order to propose new commitments for the MDUFA IV reauthorization package. Several of the newly proposed commitments build on the themes of greater transparency and communication between FDA and its stakeholders.
The new proposal calls for full-time reporting for CDRH employees as compared to time reporting during only a few weeks a year. More frequent time reporting will produce data that can be used by CDRH leadership to capacity plan and assure that MDUFA resources are better positioned to support the Center review staff. FDA will also be required to cite its justification for all deficiencies included in requests for additional information, e.g., statute, regulation, guidance, etc., to the applicant.
Additionally, the applicant will also have access to the supervisory oversight, as well as the name of the lead reviewer, for all additional information requests. This requirement will provide greater clarity and understanding of the issues for the industry in order to work interactively with the review team to resolve deficiencies more efficiently. In addition, this requirement should help to improve the consistency and training among the FDA review staff, and accountability for Center managers.
Other highlights of the proposed commitments listed for MDUFA IV create new ways for FDA and industry to improve the medical device submission process. FDA will create a submission tracker IT system for companies and FDA, to track a device's progress throughout the entire submission(s) process. This will decrease discrepancies between FDA and industry by clearly showing the status of each device in the process.
MDUFA IV will also establish meaningful performance goals for the Evaluation of Automatic Class III Designations (de novos) for the first time. These de novo goals will specifically target the statutory timeframe and will aim to increase the overall completion percentage with a targeted performance goal. Again, this should help to improve predictability of this process for industry.
In terms of quality, the MDUFA IV commitments will establish a dedicated Quality Management team. The team will conduct routine quality audits and will direct training to areas of need for premarket review. Lastly, FDA and industry will continue the independent assessment of the CDRH review processes. This independent assessment will hold FDA accountable for meeting MDUFA IV goals and commitments as well as encouraging further efficiencies.
In summary, assuring the continued preeminence of the medical device ecosystem in the United States is a complex enterprise requiring the expertise and resources of all public and private stakeholders. The medical device user fee program is a necessary component of that enterprise which has demonstrated that working together can produce tangible results and serve the needs of patients and caregivers by providing greater access to safe and effective medical devices in a timely manner.
Heather Rosecrans, FRAPS is Executive Vice President, Medical Devices and Combination Products at Greenleaf Health, an FDA regulatory consulting firm in Washington, DC. Heather also serves as the vice president of Regulatory Affairs at the Medical Device Manufacturers Association. Rosecrans has more than 30 years of experience at FDA and is a specialist in the agency's 510(k) program, which she helped develop.
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