FDA 21 CFR Part 806 Corrections and Removals

Requires reporting and records for corrections or removals of devices to reduce health risks or remedy violations.

Jurisdiction: US
Issuer: FDA
Effective: 1997-11-17

Sectors

Healthcare & Pharma Manufacturing

Articles (6)

§ 806.40 Public availability of reports.§ 806.1 Scope.§ 806.2 Definitions.§ 806.10 Reports of corrections and removals.§ 806.20 Records of corrections and removals not required to be reported.§ 806.30 FDA access to records.