The Food and Drug Administration issued a draft of updated recommendations intended to clarify when manufacturers should report medical device changes to the agency. The draft recommendations contain ...
The U.S. Food and Drug Administration has announced the availability of its final guidance on AI medical devices. The document – Marketing Submission Recommendations for a Predetermined Change Control ...
Massachusetts school uses 'skin shocks' on autistic, special needs kids. Dec. 19, 2012 — -- A Boston area school for severely disabled children has received a warning letter from the U.S. Food ...
FDA classifies medical devices based on the type of device and the level of risk it poses Three main FDA clearances for medical devices are 510(k), de novo and pre-market approval Several ASX ...
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