ComplianceOnline

New Institute of Medicine Study Proposes Scrapping of FDA’s 510(k) Submission Process

  • By: Staff Editor
  • Date: August 19, 2011
Webinar All Access Pass Subscription Abstract:

The Institute of Medicine has released a report that has found the FDA’s existing rules for the 510(k) clearance lacks the legal basis to be a reliable premarket screen of the safety and effectiveness.

The report has been criticized by the medical device industry while patient rights groups have welcomed its findings.

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