On July 14, the U.S. Food and Drug Administration (FDA) announced it is seeking public input regarding the patient safety impacts of certain medical software functions excluded from the definition of ...
On July 28, the U.S. Food and Drug Administration (FDA) issued the final guidance “Multiple Function Device Products: Policy and Considerations,” which describes FDA's regulatory approach and policy ...
A finalized guidance gives direction for sponsors on US Food and Drug Administration (FDA) review of medical products that contain both medical and non-medical functions. “The purpose of this guidance ...
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