FDA Issues Final Guidances on Postmarket Surveillance and Post-approval Studies
FDA Issues Final Guidances on Postmarket Surveillance and Post-approval Studies This month, the FDA issued two final guidances related to post-approval studies and postmarket surveillance of medical devices. Per the FDA announcement, these guidances are “intended to enhance patient safety by facilitating timely initiation and completion of post-approval studies (PAS) and postmarket surveillance under …
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