Investigational Device Exemption (IDE) Submissions for Sponsor-Investigators | Clinical Research Res

Investigational Device Exemption (IDE) Submissions for Sponsor-Investigators | Clinical Research Res

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日期:2025-07-10
Amendments, Safety Reports & Annual Reports IDE sponsor-investigators are required under 21 CFR 812.150 to submit the following reports: Unanticipated adverse device effects (UADE) A UADE is any serious adverse effect on health or safety, any life-threate...看更多