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Regulatory Focus™ > News Articles > FDA, Stakeholders Reveal Top Priorities for MDUFA IV Reauthorization

FDA, Stakeholders Reveal Top Priorities for MDUFA IV Reauthorization

Posted 12 November 2015 | By Zachary Brennan 

FDA, Stakeholders Reveal Top Priorities for MDUFA IV Reauthorization

As the US Food and Drug Administration (FDA) and industry look to deliver recommendations to Congress on the reauthorization of the Medical Device User Fee Amendments (MDUFA) by January 2017, both sides agreed to limit their focus to three top priorities for future stakeholder meetings.

The topics nominated in late October as the top priorities include how to incorporate patient perspectives into FDA reviews, how postmarket and premarket device evidence will be better utilized moving forward, particularly as unique device identifiers become mainstream, and how the various FDA centers will work together on combination products, companion diagnostics and other matters that stretch across multiple agency divisions.

An earlier MDUFA meeting in October focused on other industry and FDA discussions on FDA’s response to an industry-requested analysis of pre-submissions for investigational device exemptions (IDEs), reviewed CDRH information systems for premarket reviews and discussed the implementation of recommendations from Booz Allen Hamilton’s MDUFA II/III Evaluation and additional financial analysis.

Patient Perspective

As to the future MDUFA negotiations, both sides agreed to discuss FDA’s and industry’s resource constraints that limit the use of scientific data on patient preference and patient reported outcomes, as well as the limitations of bringing devices to market using such information, and the ways in which industry is incorporating and seeking such patient information.

The push for more patient perspective comes as back in September, FDA’s Center for Devices and Radiological Health (CDRH) announced the establishment of the first patient engagement advisory committee. As far as the committee’s initial focus, FDA is asking for public comment on that decision, though the committee may advise CDRH on guidance, clinical trial design, patient preferences, device labeling, unmet clinical needs and benefit-risk determinations.

Clinical Trials

Stakeholders at the MDUFA meeting in October also raised concerns about the proportion of women, minorities and elderly patients in industry-sponsored clinical trials, which they say is inconsistent with disease prevalence in the underlying population. Stakeholders also said enrollment criteria may result in the exclusion of some groups from clinical trials, including people with multiple conditions.

In its defense, CDRH noted that it has incorporated recommendations from final guidance on sex and gender subgroup analysis into review templates, and that it’s drafting guidance with recommendations on the evaluation and reporting of age, race, and ethnicity data in device studies.

FDA also discussed section 907 of the Food and Drug Safety and Innovation Act, which directed the agency to look at demographic data to be included in clinical trials, analyses for safety and effectiveness, and the availability of certain information on the performance of medical products in demographic subgroups.

More Data

On the postmarket end, stakeholders stressed the importance of expanding the use of registries and other means to collect device data once a device is broadly available in the US.

In addition, stakeholders suggested considering the use of user fees to cover the cost of postmarket surveillance, and reiterated the need to ensure efficient and effective postmarket data collection and use because of the way data collection in certain situations is shifting from premarket to postmarket.

“The stakeholders expressed concerns with resources (user fees) being available to maintain current programs as well as for completing outstanding action items,” FDA noted. “The stakeholders encouraged the agency to take a total product lifecycle approach as pre- and post-market cannot be dissected from each other.”

Moving Forward

For the next negotiation meeting later this month, FDA and industry agreed to present final proposals so as to reach an agreement that can go into clearance by spring of 2016.

FDA will then conduct the public process for review of draft recommendations by fall of 2016, so that the final recommendations can be delivered to Congress by 15 January, 2017, as required by law.

Stakeholder Meeting on MDUFA IV Reauthorization


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