Medical Devices; Quality System Regulation Amendments
Title:
Medical Devices; Quality System Regulation Amendments
Origin/Publisher:
FDA
Content:
CGMP requirements as set forth in the QS regulation, codified in part 820 (21 CFR part 820). FDA is accomplishing
this primarily by incorporating by reference the 2016 edition of ISO 13485 (ISO 13485). Through this rulemaking,
FDA is harmonizing quality management system requirements for
medical devices with requirements used by other regulatory authorities.