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JAMA Editorials Call For Tough FDA Sanctions, Device Coding, To Ensure Post-Market Safety

Executive Summary

Two Harvard Medical School professors argue US FDA should put pressure on device manufacturers to complete their post-market studies by withdrawing market authority for devices when sponsors do not meet post-approval commitments. Meanwhile, in the same issue of the Journal of the American Medical Association, a Michigan University researcher suggests tracking products with device-specific CPT codes.

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