Since 2003, more than 99 percent of the medical devices brought to the FDA 510k program have been cleared while less than one percent approved through the pre-market approval process, according to the article. AAOS members at the Institute of Medicine panel and FDA meetings urged both organizations to identify specific areas of improvement within the existing process and allow the FDA to determine the appropriate changes to make the review process more effective.
The AAOS is preparing comments to the FDA and IOM regarding the review process.
Read the AAOS Now report on FDA 510k clearance.
Read other coverage on AAOS:
– AAOS Article: No Statistical Difference Between Allograft and Autograft
– PRP Use for Orthopedics: Updates and Standards From AAOS
– AAOS: Vertebroplasty Ineffective in Treating Spinal Fractures
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