MASSDEVICE ON CALL — The FDA is looking for medical device companies to participate in its "Experiential Learning Program," so that the agency’s reviewers can get a 1st-hand look into medtech design and manufacturing.
Participating companies would host tours for healthcare regulators as part of a training mechanism to give the reviewers a sense of the medtech development life-cycle and the "challenges faced throughout development, testing, manufacturing, and clinical use," according to an FDA notice.
The FDA launched an ELP Pilot last year, aiming to fully launch the program this year. The tours are not inspections or regulatory reviews of the facilities, but only a means of familiarizing CDRH staff with the medical device manufacturing experience.
"This program is a collaborative effort to enhance communication and facilitate the premarket review process," the agency said. "Furthermore, CDRH is committed to understanding current industry practices, innovative technologies, and regulatory impacts and needs."
Through the notice the FDA is asking for companies to sign up as hosts for the tours. The agency’s areas of interest include reliability testing of intensive care unit ventilators and anesthesia gas machines, implantation techniques for spinal devices, clinical use of orthopedic bone void filler products and more.
The ELP program has been criticized by healthcare watchdogs, and was fingered in a recent New York Times editorial as an example of the ways in which the medical device industry and regulatory authorities are getting a bit too close.
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