Section I: North America: United States and Canada
Chapter 2: Postmarket Compliance: US
46
30. Recalls, Corrections, and Removals (Devices).
Last updated. September 2020. FDA web-
site. https://www.fda.gov/medical-devices/
postmarket-requirements-devices/recalls-correc-
tions-and-removals-devices#:~:text=Medical%20
device%20recalls%20are%20usually,810%2C%20
Medical%20Device%20Recall%20Authority.
31. 21 CFR Part 7, Enforcement Policy. Revised March
2022. FDA website. https://www.accessdata.fda.gov/
scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFR-
Part=7&showFR=1.
32. 21 CFR 810, Medical Device Recall Authority. Revised
March 2022. FDA website. https://www.accessdata.fda.
gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFR-
Part=810&showFR=1.
33. 21 CFR Part 806, Medical Devices Reports of
Corrections and Removals. Revised March 2022.
FDA website. https://www.accessdata.fda.gov/scripts/
cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=806&-
showFR=1.
34. 21 CFR Part 806.2. Current as of 20 July 2022. FDA
website. https://www.accessdata.fda.gov/scripts/cdrh/
cfdocs/cfcfr/CFRSearch.cfm?fr=806.2.
35. 21 CFR Part 7.3. Current as of 20 July 2022. FDA
website. https://www.accessdata.fda.gov/scripts/cdrh/
cfdocs/cfcfr/CFRSearch.cfm?fr=7.3.
36. Health Hazard Evaluations (HHEs) and Health
Risk Assessments (HRAs). Last updated December
2017. FDA website. https://www.fda.gov/about-fda/
cdrh-transparency/health-hazard-evaluations-hhes-
and-health-risk-assessments-hras.
37. 21 CFR Part 7.46. Current as of 20 July 2022. FDA
website. https://www.accessdata.fda.gov/scripts/cdrh/
cfdocs/cfcfr/CFRSearch.cfm?fr=7.46.
38. 21 CFR Part 7.42. Current as of 20 July 2022. FDA
website. https://www.accessdata.fda.gov/scripts/cdrh/
cfdocs/cfcfr/CFRSearch.cfm?fr=7.42.
39. 21 CFR Part 7.55. Current as of 20 July 2022. FDA
website. https://www.accessdata.fda.gov/scripts/cdrh/
cfdocs/cfcfr/CFRSearch.cfm?fr=7.55.
40. 21 CFR Part 821, Medical Device Tracking
Requirements. Revised March 2022. FDA website.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/
cfcfr/CFRSearch.cfm?CFRPart=821&showFR=1.
41. Guidance Document. Medical Device Tracking.
Guidance for Industry and Food and Drug
Administration Staff. March 2014. Final. FDA
website. https://www.fda.gov/regulatory-information/
search-fda-guidance-documents/medical-device-track-
ing.
42. 21 CFR Part 821.60. Current as of 20 July 2022. FDA
website. https://www.accessdata.fda.gov/scripts/cdrh/
cfdocs/cfcfr/CFRSearch.cfm?fr=821.60.
43. 21 CFR Part 821.25. Current as of 20 July 2022. FDA
website. https://www.accessdata.fda.gov/scripts/cdrh/
cfdocs/cfcfr/CFRSearch.cfm?fr=821.25.
44. 21 CFR Part 821.30. Current as of 20 July 2022. FDA
website. https://www.accessdata.fda.gov/scripts/cdrh/
cfdocs/cfcfr/CFRSearch.cfm?CFRPart=821&show-
FR=1&subpartNode=21:8.0.1.1.13.3.
45. 21 CFR Part 801, Labeling. Revised March 2022.
FDA website. Unique Device Identification System,
Final Rule, 78 FR 58785. (24 September 2013).
Federal Register website. https://www.federalregister.
gov/documents/2013/09/24/2013-23059/unique-de-
vice-identification-system.
46. 21 CFR Part 830, Unique Device Identification.
Revised March 2022. FDA website https://www.access-
data.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.
cfm?CFRPart=830&showFR=1.
47. Unique Device Identification System, Final Rule,
78 FR 58785. (24 September 2013). Federal
Register website. https://www.federalregister.gov/
documents/2013/09/24/2013-23059/unique-de-
vice-identification-system.
48. 21 CFR Part 830.20. Current as of 20 July 2022. FDA
website. https://www.accessdata.fda.gov/scripts/cdrh/
cfdocs/cfcfr/cfrsearch.cfm?fr=830.20.
49. 21 CFR Part 801.45. Current as of 20 July 2022. FDA
website. https://www.accessdata.fda.gov/scripts/cdrh/
cfdocs/cfcfr/CFRSearch.cfm?fr=801.45.
50. 21 CFR Part 801.18. Current as of 20 July 2022. FDA
website. https://www.accessdata.fda.gov/scripts/cdrh/
cfdocs/cfcfr/CFRSearch.cfm?fr=801.18.
51. Guidance Document. Global Unique Device
Identification Database (GUDID): Guidance for
Industry and Food and Drug Administration Staff. June
2014. Final. FDA website. https://www.fda.gov/regu-
latory-information/search-fda-guidance-documents/
global-unique-device-identification-database-gudid.
52. 21 CFR Part 830.310. Current as of 20 July 2022. FDA
website. https://www.accessdata.fda.gov/scripts/cdrh/
cfdocs/cfcfr/CFRSearch.cfm?fr=830.310.
53. 21 CFR Part 830.50. Current as of 20 July 2022. FDA
website. https://www.accessdata.fda.gov/scripts/cdrh/
cfdocs/cfcfr/CFRSearch.cfm?fr=830.50.
54. Benefits of a UDI System. Last updated September
2018. FDA website. https://www.fda.gov/medical-de-
vices/unique-device-identification-system-udi-system/
benefits-udi-system.
55. About FDA. FDA website. https://www.fda.gov/about-
fda.