Index
After clearance
Clearance is the start of a set of obligations that continue for the life of the device. Four of them have their own page.
21 CFR 807 subpart B; 820; 830; 801; 803
- QMSRThe quality system rule, in force since February 2026, and why an ISO 13485 certificate is not enough.21 CFR 820
- UDI and GUDIDWho counts as the labeler, and what goes into the public database.21 CFR 830; 801 subpart B
- Device labelingWhat must appear on a device label, and the claims that cannot.21 CFR 801
- Adverse event reportingWhat must be reported to FDA, by whom, and within what deadline.21 CFR 803
Establishment registration renews every year between 1 October and 31 December (21 CFR 807.21). A registration that lapses is not a paperwork problem — devices from an unregistered establishment are misbranded.