Source: https://www.ecfr.gov/cgi-bin/text-idx?mc=true&node=se21.8.806_11&rgn=div8
Timestamp: 2020-01-17 14:51:36
Document Index: 526278022

Matched Legal Cases: ['art 806', '§806', '§806', '§806', '§806', '§806']

Title 21 → Chapter I → Subchapter H → Part 806 → Subpart A → §806.1
§806.1 Scope.
(a) This part implements the provisions of section 519(g) of the Federal Food, Drug, and Cosmetic Act (the act) requiring device manufacturers and importers to report promptly to the Food and Drug Administration (FDA) certain actions concerning device corrections and removals, and to maintain records of all corrections and removals regardless of whether such corrections and removals are required to be reported to FDA.
(2) Market withdrawal as defined in §806.2(i)
(3) Routine servicing as defined in §806.2(l).
(4) Stock recovery as defined in §806.2(m).
[62 FR 27191, May 19, 1997, as amended at 63 FR 42232, Aug. 7, 1998; 84 FR 12083, Apr. 1, 2019]