The Accreditation Scheme for Conformity Assessment Program; Draft Guidances for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff; Availability

Issuing agencies

Abstract

The Food and Drug Administration (FDA or Agency) is announcing the availability of three draft guidance documents for the Accreditation Scheme for Conformity Assessment Program entitled "The Accreditation Scheme for Conformity Assessment (ASCA) Program; Guidance for Industry, Accreditation Bodies, Testing Laboratories, and FDA Staff;" "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: Guidance for Industry, Accreditation Bodies, Testing Laboratories, and FDA Staff;" and "Biocompatibility Testing of Medical Devices--Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Program: Guidance for Industry, Accreditation Bodies, Testing Laboratories, and FDA Staff." In accordance with amendments made by the FDA User Fee Reauthorization Act of 2022 (FUFRA), part of the Medical Device User Fee Amendments of 2022 (MDUFA V), FDA was directed to conclude the Pilot Accreditation Scheme for Conformity Assessment Program by the end of fiscal year 2023 and continue to operate the program (hereafter referred to as the ASCA Program) consistent with the amended FD&C Act. FDA is publishing these draft guidance documents which, when finalized, are intended to provide updates to improve the ASCA Program. These draft guidance documents are not final nor for implementation at this time.