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.
This control maps to 1 controls across 1 other frameworks. If you already hold one of them, the evidence you collected for it is the starting point here rather than new work.
Every mapping shown was judged rather than inferred from wording similarity, and the ones that failed review are published too. See the coverage reports and what was rejected.
The graph holds this control, the 1 it maps to, and the evidence behind each claim, over MCP and REST.