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.