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美國FDA公布510(k)醫療器材上市前許可指引針對醫療器材上市前之審查規範提出更完善詳細之調整

參考文獻


The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)], http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM284443.pdf (last visited Jan. 23, 2015)
(2012).Improvements in Device Review.,未出版U.S FOOD AND DRUG ADMINISTRATION.
21 U.S.C. §360c(a)(1)(A)、§360c(a)
Initial Results of 510(k) Audit - Analysis of Not Substantially Equivalent (NSE) Determinations, available at http://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cdrh/cdrhreports/ucm259173.htm (last visited at Jan 23, 2015)
(2012).Regulation and Access to Innovative Medical Technologies.,未出版BOTON CONSULTING GROUP.

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