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CDRH Industry: FDA Announcing Two Draft Guidance Documents Clarifying When to Submit a 510(k) for a Change to an Existing Device and Webinar on August 25, 2016

CDRH Industry: FDA Announcing Two Draft Guidance Documents Clarifying When to Submit a 510(k) for a Change to an Existing Device and Webinar on August 25, 2016

  • Admin
  • August 5, 2016
  • News / US FDA

Today the FDA released two draft guidance documents: “Deciding When to Submit a 510(k) for a Change to an Existing Device,” which applies to medical device changes broadly, and “Deciding…

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