Source: https://www.federalregister.gov/documents/2010/11/23/2010-29520/agency-information-collection-activities-proposed-collection-comment-request-reports-of-corrections
Timestamp: 2018-07-19 21:57:55
Document Index: 88037531

Matched Legal Cases: ['art 806', 'art 806', '§\u2009806', '§\u2009806', '§\u2009806', '§\u2009806', '§\u2009806', '§\u2009806', '§\u2009806', '§\u2009806', '§\u2009806', 'art 806']

Submit either electronic or written comments on the collection of information by January 24, 2011.
https://www.federalregister.gov/d/2010-29520 https://www.federalregister.gov/d/2010-29520
The collection of information required under the reports of corrections and removals, part 806 (21 CFR part 806), implements section 519(g) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360i(g)), as amended by the Food and Drug Administration Modernization Act (FDAMA) of 1997 (21 U.S.C. 301) (Pub. L. 105-115). Each device manufacturer or importer under § 806.10 shall submit a written report to FDA of any action initiated to correct or remove a device to reduce a risk to health posed by the device, or to remedy a violation of the FD&C Act caused by the device that may present a risk to health, within 10 working days of initiating such correction or removal. Each device manufacturer or importer of a device who initiates a correction or removal of a device that is not required to be reported to FDA under § 806.20 shall keep a record of such correction or removal.
The information collected in the reports of corrections and removals will be used by FDA to identify marketed devices that have serious problems and to ensure that defective devices are removed from the market. This will assure that FDA has current and complete information regarding these corrections and removals and to determine whether recall action is adequate.Start Printed Page 71447
806.10 666 1 666 10 6,660
806.20 90 1 90 10 900
This information is relevant since a § 806.10 report is required for all class I and II recalls. Although class III recalls are not required to be submitted to FDA (by § 806.10) a record must be kept in the firm's § 806.20 file. Therefore, the number of class I and II recalls can be used to estimate the maximum number of reports that are required to be submitted under § 806.10. Also, the recordkeeping burden can be estimated based upon the number of class III recalls, which are not required to be reported but must be retained in a § 806.20 file.
FDA has determined that estimates of the reporting burden for § 806.10 should be revised to reflect a projected 7.3 percent increase (from the last PRA numbers) in reports submitted to FDA as class I and II. FDA also estimates the recordkeeping burden in § 806.20 should be revised to reflect a reduction of 6.8 percent (from the last PRA numbers) in records filed and maintained under this section. The estimates of time needed to collect part 806 information have not changed.