MDSAP Audit Approach (MDSAP AU P0002) C2-T3-US: For the United States, update registration and listing, file new 510(k)s or PMA supplements for significant changes, and keep changes within any agreed predetermined change control plan

What does C2-T3-US require?

Device listings must be reviewed and updated between 1 October and 31 December (or when a change occurs), including newly listed classification names and discontinued device classes, and registration updated within 30 days of ownership, structure or location changes. A new 510(k) is usually needed for changes that could significantly affect safety or effectiveness or that add a new indication (for example sterilisation method, materials, manufacturing method, operating parameters, safety features, sterile barrier packaging, stability claims or design). PMA holders must obtain approval of a supplement before changes affecting safety or effectiveness (new indications, labelling, facilities, sterilisation, packaging, specifications, expiry extensions), reporting other changes in periodic reports. Where a predetermined change control plan was cleared or approved, changes must stay within the modifications it prespecified. Clauses: ISO 13485:2016 7.3.9; 21 CFR 807, 807.81, 814.39.