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

This guidance provides information on how the Biological Evaluation of Medical Devices standards are incorporated into the Pilot Accreditation Scheme for Conformity Assessment Program (hereafter referred to as the ASCA Pilot). The ASCA Pilot is described in FDA’s guidance The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program…