The basics of FDA’s ASCA program

Recently, the FDA updated three ASCA guidances, namely:

📍 The Accreditation Scheme for Conformity Assessment (ASCA) Program

📍 Biocompatibility Testing of Medical Devices – Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Program

📍Basic Safety and Essential Performance of Medical Electrical Equipment, Medical Electrical Systems, and Laboratory Medical Equipment– Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Program

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This morning, Evnia summarises the basics of the voluntary ASCA Program, designed to accredit testing laboratories to perform premarket testing for medical device companies to speed up FDA review times while improving the quality of conducted testing.