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Food and Drug Administration (FDA) › Clearance

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FDA Announces Plans for Alternative Clearance Pathway

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The U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb recently announced that the agency plans to publish a draft guidance outlining a voluntary alternative pathway for new, moderate-risk devices for use in...more

Knobbe Martens

First-Ever De Novo Clearance by FDA’s Orthopedic Branch

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According to IlluminOss Medical, Inc.’s recent press release, the company has successfully obtained the first-ever de novo clearance from the FDA’s Orthopedic Branch for its minimally invasive bone stabilizaion system (the...more

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