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Shuren: More Than A Dozen MDDTs Under Review, But No More This Year

The head of US FDA's device center says there are a substantial number of medical device development tools under review by the agency that could help speed up data collection for product approvals and clearances, but they are not likely to be OK'd by the agency until next year.

The US FDA device center has received several dozen medical device development tools (MDDT) for the agency to review and qualify, and more than a dozen are currently being evaluated, according to center director Jeff Shuren. But, he said Dec. 6 at the FDA-CMS Summit (Informa KNect365 Life Sciences) in Washington, D.C., no new MDDTs are likely to be granted qualification before the year's end.

In August, FDA released a final guidance what it would require to qualify an MDDT. The tools are methods, materials, or measurements used to assess device performance or safety. For...

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