In The News

In Bloomberg Law, Life Sciences Co-Chair Addresses FDA Medical Device Clearance Proposal

Practices: Life Sciences, FDA Regulatory

Life sciences partner Gregory Levine (Washington, D.C.) was quoted in an April 16 article in Bloomberg Law’s Life Sciences Law & Industry Report that discusses the U.S. Food and Drug Administration proposal for a more flexible approach to clear certain medical devices.

Mr. Levine notes the challenge will be getting specific medical devices qualified for inclusion in the new program. The FDA draft guidance does not make clear which devices would be eligible to use the new performance criteria.

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