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Equipment – Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Program: Draft Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff

Issue Date: September 23, 2024
Issued by: Center for Devices and Radiological Health
Topic(s): Premarket,
Status: Draft

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Equipment – Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Program: Draft Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff

This guidance provides information regarding how basic safety and essential performance standards are incorporated into the Accreditation Scheme for Conformity Assessment Program (hereafter referred to as the ASCA Program). The ASCA Program is described in FDA’s guidance, The Accreditation Scheme for Conformity Assessment (ASCA) Program.

Download the Guidance Document