The GAO report said the FDA has not been reviewing recall data to find patterns that might indicate systemic problems. Citing the report, Senators Chuck Grassley (R-Iowa) and Herb Kohl (D-Wis.) called on the FDA to revamp its recall process.
“Recalls are typically voluntary, and patients would be better served if the FDA took a thorough approach to post-market surveillance of medical devices,” Sen. Grassley said in a release. “The FDA is missing an opportunity to proactively identify and address risks presented by unsafe devices.”
Read the GAO report on device recalls.
Read the Sen. Grassley release on device recalls.
Related Articles on the FDA Recall Process for Medical Devices:
Anesthesiology Devices Recalled After Weak Oversight by FDA
Study: Recalled Medical Devices Were Cleared Through Less-Stringent 510(k) Process
Study: No Safety Benefit Recognized From Slower, Burdensome FDA Approval Process for Devices
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