FDA Part 806.docVIP

[Code of Federal Regulations] [Title 21, Volume 8] [Revised as of April 1, 2011] [CITE: 21CFR806]  TITLE 21--FOOD AND DRUGSCHAPTER I--FOOD AND DRUG ADMINISTRATIONDEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER H--MEDICAL DEVICES ? PART 806 MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS ? Subpart A--General Provisions Sec. 806.1 Scope. (a) This part implements the provisions of section 519(f) 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. 这部分执行《联邦食品、 药品和化妆品法案 》 （法） 519(f) 章节的条款，要求器械制造商和进口商向食品和药物管理局 (FDA) 迅速报告某些操作有关设备更正和清除，并保持记录的所有更正和清除无论这种更正和清除是否需要向 FDA 报告。 (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 withdrawals as defined in 806.2(h). (3) Routine servicing as defined in 806.2(k). (4) Stock recoveries as defined in 806.2(l). [62 FR 27191, May 19, 1997, as amended at 63 FR 42232, Aug. 7, 1998] Sec. 806.2 Definitions. As used in this part: (a)Act means the Federal Food, Drug, and Cosmetic Act. (b)Agency or FDA means the Food and Drug Administration. (c)Consignee means any person or firm that has received, purchased, or used a device subject to correction or removal. (d)Correction means the repair, modification, adjustment, relabeling, destruction, or inspection (including patient monitoring) of a device without its physical removal from its point of use to some other location. (e)Correction or removal report number means the number that uniquely identifies ea