FDA Quality Management System Regulation (QMSR) QMSR-820.1_3_7: Scope, definitions and incorporation by reference (§§820.1, 820.3, 820.7)

What does QMSR-820.1_3_7 require?

Section 820.1 (Scope): the QMSR establishes requirements for the methods used in + the facilities + controls used for the design + manufacture + packaging + labelling + storage + installation + servicing of all finished medical devices intended for human use. Section 820.3 (Definitions) applies the terms and definitions of ISO 13485:2016 clause 3 and adds FDA-specific definitions, among them component, finished device and manufacturer. The QMSR drops the former QSR terms device master record (DMR), device history record (DHR) and design history file (DHF); their content is carried by the ISO 13485 medical device file (4.2.3), the record kept for each device or batch (7.5.1) and the design and development file (7.3.10). Section 820.7 (Incorporation by reference): the FDA incorporates ISO 13485:2016 by reference making the ISO standard MANDATORY for QMSR compliance. The FDA + ISO 13485:2016 + the QMSR Final Rule together form the harmonised US medical-device quality framework. Compliance with QMSR requires manufacturers to: (a) hold a current copy of ISO 13485:2016 + the QMSR Final Rule + (b) implement all ISO 13485:2016 Sections 4-8 + QMSR §§820.10-820.45.