Minnesota is a mecca for medical device manufacturers, so Dr. Jeffrey Shuren, who heads the device division of the Food and Drug Administration (FDA) made it one of his first stops after the second warning about synthetic surgical mesh by the FDA, and an Institute of Medicine criticism of the 510 (k) process that allows devices to be marketed bypassing clinical trials.
The medical device industry is understandably nervous.
Med City News reports in this article, here, that the FDA does not have enough experienced reviewers to determine which medical devices should be approved. At the invitation of a Minnesota medical device trade group, Shuren assured the group that the FDA will begin a reviewer certification and training program starting in September. This will be a new program that “should help in the certification of medical devices.”
Dr. Shuren seemed reluctant to use a third-party reviewer program, reports the paper.
MedCity News followed-up with this article on a private-public partnership suggested by the medical device community to Dr. Shuren during his visit. It will be focused on “regulatory science” which uses tools to evaluate medical devices and allows more access by the industry into the regulatory process.