Watchdog Group Blasts FDA’s Dwindling Oversight Of Non-Clinical Labs
This article was originally published in The Gray Sheet
Executive SummaryA nonprofit government watchdog group is criticizing FDA for scaling back inspections of laboratories that test medical devices early in the development process, before they are tested in humans
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Device industry experts say a seemingly minor footnote to the recent 510(k) program draft guidance could create a new requirement for nonclinical studies.
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