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

• By: Staff Editor
• Date: August 19, 2011

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.