The FDA’s reviewer certification program will become an agency-wide requirement this month, aimed at shortening medical device review times through a more prepared staff.
The 18-month training program will apply to all new device reviewers from the Centers for Devices & Radiological Health’s anaesthesia, general hospital, infection control and dental devices divisions.
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"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," CDRH chief Dr. Jeffrey Shuren said in prepared remarks. "This investment will improve the quality of submission review and make the process more consistent and predictable."
Meanwhile, the House Energy & Commerce Committee’s Health panel plans to spend the fall focused on tweaking the FDA regulatory process for medical devices and prescription drugs, citing the need to get a competitive edge on overseas markets with more favorable regulatory conditions, according to the recently released agenda.
"The. U.S. traditionally has been the leader in the medical device industry employing an estimated 420,000 Americans, but the lack of predictability and consistency at FDA currently force research and development, manufacturing and new product approvals to Europe, costing American jobs and limiting U.S. patients’ access to revolutionary new devices," according to the release.
Demands for more consistency and predictability have been a frequent call from the med-tech industry, including during the MassDevice Big 100 Regional Roundtable event in Waltham, Mass. in July, where Shuren cited high reviewer turnover and a lack of experience as one of the reasons companies encounter uncertainty during the device review process.
In addition to the reviewer certification program, the FDA is piloting an "experiential learning program" to give premarket reviewers a view of the medical device process from the other side of the table. The program will include visits to academic institutions, manufacturers, research organizations and health care facilities where they’ll see first-hand the challenges of med-tech design and manufacturing.
The experiential learning program will begin as a pilot in 2012.
The educational efforts allow CDRH to check off one more box on the 25-item Plan of Action for Implementation of 510(k) and Science Recommendations, a list of milestones and guidelines the agency hopes to reach this year to make the 510(k) process a "blueprint for smarter medical device oversight; one that drives innovation and brings important technologies to patients."
The agency has also released guidelines for designing clinical studies for PMA submissions issued guidance on proposed changes to the 510(k) fast-track review.
