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HHS - 21 CFR PART 806

MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS

active, Most Current
Organization: HHS
Publication Date: 1 April 2019
Status: active
Page Count: 5
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.

(b) The following actions are exempt from the reporting requirements of this part:

(1) Actions taken by device manufacturers or importers to improve the performance or quality of a device but that do not reduce a risk to health posed by the device or remedy a violation of the act caused by the device.

(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]

Document History

April 1, 2020
MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS
(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...
21 CFR PART 806
April 1, 2019
MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS
(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...
April 1, 2018
MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS
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...
April 1, 2017
MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS
(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...
April 1, 2016
MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS
(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...
April 1, 2015
MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS
(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...
April 1, 2014
MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS
(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...

References

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