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) Pilot Program: Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff

Issue Date: September 25, 2020
Issued by: Center for Biologics Evaluation and Research
Topic(s): Premarket,
Status: Final

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) Pilot Program: Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff

This guidance provides information regarding how the basic safety and essential performance 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 . For the edition of the FDA-recognized consensus standard(s) included in the ASCA Pilot, see the FDA Recognized Consensus Standards Database . For more information regarding use of consensus standards in regulatory submissions, please refer to FDA’s guidance Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices and Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research .

Download the Guidance Document