FDA DRAFT GUIDANCE on Basic Safety and Essential Performance of Medical Electrical Equipment, Medical Electrical Systems, and Laboratory Medical Equipment

Document issued on September 23, 2024.

 

FDA DRAFT GUIDANCE on Basic Safety and Essential Performance of Medical Electrical Equipment, Medical Electrical Systems, and Laboratory MedicalEquipment – Standards SpecificInformation for the Accreditation Scheme for Conformity Assessment (ASCA) Program

Draft Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff