FDA Revamps Medical Device Approval; to Streamline and Clarify Review Process

InformationWeek -- The Food and Drug Administration unveiled Wednesday a plan to revamp its 510(k) program that medical device manufacturers use to clear their products before they can be marketed and sold to the public. Many medical device manufacturers see the efficient running of the 510(k) program as pivotal to stimulating U.S. innovation, investment, and job growth in the medical device industry.

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