(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]