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[NǑ(uNePgevSbv;TThV{|NT 傧NT'`0;TTPg(I{N] N^NTX[(W]_'` NO`8^ĉv[[xvzTs gpenc NNċNNT[hQ'`T gHe'` [_U\Rir[0SY ǏRir[Snx[NT4N^vsQSpeY~~S^I{ KmNT(WNSO-NO(ueSQsv[hQ'`0 ASN S8T6eYy2|ޏNT [NS8T6eYy2|ޏNT ^[sNTgv2|ޏR0募R[(WS_v;mSORir!jW NۏLxvz0Rir[-N[=\S0WSOsKb/gel0yr[Kb/gMO0|ޏv{|W0|ޏvċNe_ NSb(W4N^^(uevNTO(uel v^‰[NT/f&T gHeMNO|ޏvSus0^l z^S%N͑ z^I{0SY ǏRir[_NSNf}Y0W:N4N^xvzeHhcOS0 N0SDe [1] General Considerations for Animal Studies for Medical Devices Draft Guidance [2] EFS Guidance:  HYPERLINK "https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm279103.pdf" Investigational Device Exemptions IDEs for Early Feasibility Medical Device Clinical studies, Including Certain First in Human FIH Studies [3] Recommended Content and Format of Test Reports for Complete Non-Clinical Bench Performance Testing in Premarket Submissions Draft Guidance [4] 0Xo~~RrRbk@|~b/g[gc[SR 0V[ߘToTvcw{t;`@\JT2018t^,{37S [5] 0T\(u;TThVNTlQb/g[gc[SR 0V[ߘToTvcw{t;`@\JT2017t^,{44S [6] 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