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Home » AdvaMed Calls for Broader Scope in FDA Draft Guidance on Trial Safety
AdvaMed Calls for Broader Scope in FDA Draft Guidance on Trial Safety
The FDA’s draft guidance on investigator safety responsibilities in device and drug clinical trials discusses reporting unanticipated adverse device effects (UADEs) for investigational devices during a premarket study conducted under an investigational device exemption (IDE), but the agency should clarify if that also “applies to retrospective postmarket studies or real-world evidence (RWE) investigations,” Advanced Medical Technology Association (AdvaMed) said in a written comment to the agency.