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FDA seeking more insight from manufacturers

April 16, 2015
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The CDRH is making an effort to learn more about the challenges faced in broader disciplines that impact the device development life cycle.

The FDA began its Experiential Learning Program (ELP) with the hope of “closing the knowledge gap between emerging and innovative technology and the pre-market review of the resulting medical devices,” according to its official site. The program aimed to improve communication between the agency and medical device manufacturers, helping both parties to better understand how medical devices are developed, clinically tested, manufactured and used.

Now, the FDA is in the midst of expanding the program, in order to learn more about emerging medical device technologies and how these might effect the current regulatory environment. This effort includes groups of CDRH staff visiting research, production and health care facilities to gain first-hand experience and learn how regulatory function might be improved in light of their findings.

“We are investing resources so that new device reviewers at CDRH are equipped to handle the range of issues that arise during the premarket device reviews,” said CDRH Director Jeffery Shuren in a press statement. “This investment will improve the quality of submission review and make the process more consistent and predictable.” 

Since the program was first introduced in 2011, the FDA has identified several key areas of interest, and reached out to manufacturers to improve transparency. 

Now, the agency has identified 34 new areas of interest, which developers should be aware of. CDRH staff are also interested in improving their understanding of radiologic analysis of orthopedic devices, including visits to radiologic imaging core laboratories. They hope to engage in dialogue with manufacturers about production and regulatory challenges in order to speed approvals and assess regulatory function. 

Participation in these programs offers manufacturers valuable insight into the approval process and improves working relationships with regulatory professionals. While the FDA staff will not judge or assess developers, the experience can help manufacturers and trial sponsors more effectively prepare their submissions for approval, helping to speed time-to-market. More information on the ELP, including a sample request and agenda, is available here

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