FDA Quality Management System Regulation (QMSR) QMSR-820.15: Clarification of concepts (§820.15)

Section 820.15 provides FDA-specific CLARIFICATIONS to ensure that ISO 13485:2016 terminology aligns with FDA's interpretation of the Federal Food, Drug, and Cosmetic Act + related FDA regulations. KEY CLARIFICATIONS include: (a) 'CUSTOMER' for QMSR purposes includes patients + clinicians + the FDA + healthcare facilities + procurement entities - broader than the ISO 13485 organizational customer; (b) 'PRODUCT' refers to FINISHED MEDICAL DEVICES (i.e. devices ready for placing on the market) + does not include components + materials + sub-assemblies that have not yet been assembled into a finished device; (c) 'REGULATORY REQUIREMENTS' includes all FDA + State + International medical device regulations applicable to the manufacturer + the finished device; (d) 'COMPLAINT' (under ISO 13485 Section 7.2.3) is harmonised with the FDA definition of complaint under §820.3 + §820.198 - includes any written + electronic + oral communication that alleges deficiencies; (e) 'ADVISORY NOTICE' alignment with FDA Reports of Corrections and Removals under §806; (f) 'POST-MARKET SURVEILLANCE' alignment with FDA Section 522 post-market surveillance studies + 21 CFR Part 822.