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CDRH plans to roll out 12 final guidance documents in fiscal 2014, including guidances on cybersecurity, the device appeals process and the global unique device identification database, or GUDID, the center revealed Thursday. Read More
The International Medical Device Regulators Forum will launch its medical device single audit program (MDSAP) pilot in January in the U.S., Canada, Australia and Brazil. Read More
FDA investigators increasingly are shifting from “top down” inspections focused on policies to “bottom up” inspections that focus on raw data, an industry insider says. Read More
Revisions to the FDA’s Regulatory Procedures Manual don’t add any clarity on when a product removal is a recall and when it’s a market withdrawal, attorneys say. Read More