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

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) incorporates the definitions in ISO 13485:2016 Sections 3.1-3.20 + adds 7 FDA-specific definitions: (a) act + (b) finished device + (c) manufacturer + (d) device master record (DMR) + (e) device history record (DHR) + (f) design history file (DHF) + (g) quality system. 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.