Postmarket Requirements for Medical Devices: A Practical Guide
45
4. CFR Title 21—Food and Drugs: Part 862 to 892. FDA
website. https://www.accessdata.fda.gov/scripts/cdrh/
cfdocs/cfcfr/CFRSearch.cfm?CFRPartFrom=862&C-
FRPartTo=892.
5. 21 CFR Part 820.30. Current as of 20 July 2022. FDA
website. https://www.accessdata.fda.gov/scripts/cdrh/
cfdocs/cfcfr/CFRSearch.cfm?fr=820.30.
6. 21 CFR 807. Establishment Registration and Device
Listing for Manufacturers and Initial Importers of
Devices. Revised March 2022. FDA website. https://
www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/
CFRSearch.cfm?CFRPart=807&showFR=1.
7. 21 USC Section 360. Registration of producers of
drugs or devices. FDA website. https://www.govinfo.
gov/content/pkg/USCODE-2010-title21/html/
USCODE-2010-title21-chap9-subchapV-partA-
sec360.htm.
8. 21 CFR Part 807.20. Current as of 20 July 2022. FDA
website. https://www.accessdata.fda.gov/scripts/cdrh/
cfdocs/cfcfr/CFRSearch.cfm?CFRPart=807&show-
FR=1&subpartNode=21:8.0.1.1.5.2.
9. Who must register, list and pay the fee. Last Updated
September 2018. FDA website. https://www.fda.gov/
medical-devices/device-registration-and-listing/who-
must-register-list-and-pay-fee.
10. 21 CFR Part 820.100. Current as of 20 July 2022. FDA
website. https://www.accessdata.fda.gov/scripts/cdrh/
cfdocs/cfcfr/cfrsearch.cfm?fr=820.100.
11. FDA Center for Devices and Radiological Health. Last
updated February 2022. FDA website. https://www.fda.
gov/about-fda/fda-organization/center-devices-and-ra-
diological-health.
12. Guidance Document. Postmarket Surveillance Under
Section 522 of the Federal Food, Drug, and Cosmetic
Act. Draft Guidance for Industry and FDA Staff. May
2021. Final. FDA website. https://www.fda.gov/regu-
latory-information/search-fda-guidance-documents/
postmarket-surveillance-under-section-522-feder-
al-food-drug-and-cosmetic-act.
13. 21 CFR Part 822.8. Current as of 20 July 2022. FDA
website. https://www.accessdata.fda.gov/scripts/cdrh/
cfdocs/cfcfr/CFRSearch.cfm?fr=822.8.
14. 21 CFR Part 822.10. Current as of 20 July 2022. FDA
website. https://www.accessdata.fda.gov/scripts/cdrh/
cfdocs/cfcfr/CFRSearch.cfm?fr=822.10.
15. 21 CFR 822 Subpart D-FDA Review and Action.
Current as of 20 July 2022. FDA website. https://
www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/
CFRSearch.cfm?CFRPart=822&showFR=1.
16. 21 CFR Part 822.38. Current as of 20 July 2022. FDA
website. https://www.accessdata.fda.gov/scripts/cdrh/
cfdocs/cfcfr/CFRSearch.cfm?fr=822.38.
17. 21 CFR Part 822.20. FDA website. https://www.access-
data.fda.gov/scripts Current as of 20 July 2022. cdrh/
cfdocs/cfcfr/CFRSearch.cfm?fr=822.20.
18. Compliance and Enforcement. Last updated August
2022. FDA website. https://www.fda.gov/animal-veteri-
nary/compliance-enforcement.
19. Criminal Investigations. Last updated July 2022.
FDA website. https://www.fda.gov/inspections-com-
pliance-enforcement-and-criminal-investigations/
criminal-investigations.
20. United States Department of Justice. Freedom of
Information Act (FOIA) website. https://www.foia.
gov/.
21. 21 CFR 803, Medical Device Reporting. Revised
March 2022. FDA website. https://www.accessdata.fda.
gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFR-
Part=803.
22. Medical Devices Device Tracking, Final Rule,
67 FR 5943. 8 February 2002. Federal Register
website. https://www.federalregister.gov/
documents/2002/02/08/02-3076/medical-devices-de-
vice-tracking#:~:text=Current%20section%20519(e)
(,be%20implanted%20in%20the%20human.
23. 21 CFR 803.3. Current as of 20 July 2022. FDA
website. https://www.accessdata.fda.gov/scripts/cdrh/
cfdocs/cfcfr/cfrsearch.cfm?fr=803.3.
24. Information about reporting adverse events
to FDAs MedWatch Program. Last Updated
February 2018. FDA website. https://www.
fda.gov/safety/medwatch-fda-safety-informa-
tion-and-adverse-event-reporting-program/
information-about-reporting-adverse-events-fdas-med-
watch-program.
25. MedWatch Forms for FDA Safety Reporting. Last
updated February 2020. FDA website. https://www.fda.
gov/safety/medical-product-safety-information/med-
watch-forms-fda-safety-reporting.
26. Medical Device Reporting: Electronic Submission
Requirements, Final Rule, 79 FR 8832. 14 February
2014. Federal Register website. https://www.feder-
alregister.gov/documents/2014/02/14/2014-03279/
medical-device-reporting-electronic-submission-re-
quirements.
27. Guidance Document. Questions and Answers
about eMDR-Electronic Medical Device
Reporting: Guidance for Industry, User Facilities,
and FDA Staff. February 2014. Final.FDA
website. https://www.fda.gov/regulatory-in-
formation/search-fda-guidance-documents/
questions-and-answers-about-emdr-electronic-medi-
cal-device-reporting-guidance-industry-user.
28. About Manufacturer and User Facility Device
Experience (MAUDE). Last updated May
2022. FDA website. https://www.fda.gov/
medical-devices/mandatory-reporting-requirements-man-
ufacturers-importers-and-device-user-facilities/
about-manufacturer-and-user-facility-device-experi-
ence-maude.
29. 21 CFR Part 803.19. Current as of 20 July 2022. FDA
website. https://www.accessdata.fda.gov/scripts/cdrh/
cfdocs/cfcfr/CFRSearch.cfm?fr=803.19.
45
4. CFR Title 21—Food and Drugs: Part 862 to 892. FDA
website. https://www.accessdata.fda.gov/scripts/cdrh/
cfdocs/cfcfr/CFRSearch.cfm?CFRPartFrom=862&C-
FRPartTo=892.
5. 21 CFR Part 820.30. Current as of 20 July 2022. FDA
website. https://www.accessdata.fda.gov/scripts/cdrh/
cfdocs/cfcfr/CFRSearch.cfm?fr=820.30.
6. 21 CFR 807. Establishment Registration and Device
Listing for Manufacturers and Initial Importers of
Devices. Revised March 2022. FDA website. https://
www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/
CFRSearch.cfm?CFRPart=807&showFR=1.
7. 21 USC Section 360. Registration of producers of
drugs or devices. FDA website. https://www.govinfo.
gov/content/pkg/USCODE-2010-title21/html/
USCODE-2010-title21-chap9-subchapV-partA-
sec360.htm.
8. 21 CFR Part 807.20. Current as of 20 July 2022. FDA
website. https://www.accessdata.fda.gov/scripts/cdrh/
cfdocs/cfcfr/CFRSearch.cfm?CFRPart=807&show-
FR=1&subpartNode=21:8.0.1.1.5.2.
9. Who must register, list and pay the fee. Last Updated
September 2018. FDA website. https://www.fda.gov/
medical-devices/device-registration-and-listing/who-
must-register-list-and-pay-fee.
10. 21 CFR Part 820.100. Current as of 20 July 2022. FDA
website. https://www.accessdata.fda.gov/scripts/cdrh/
cfdocs/cfcfr/cfrsearch.cfm?fr=820.100.
11. FDA Center for Devices and Radiological Health. Last
updated February 2022. FDA website. https://www.fda.
gov/about-fda/fda-organization/center-devices-and-ra-
diological-health.
12. Guidance Document. Postmarket Surveillance Under
Section 522 of the Federal Food, Drug, and Cosmetic
Act. Draft Guidance for Industry and FDA Staff. May
2021. Final. FDA website. https://www.fda.gov/regu-
latory-information/search-fda-guidance-documents/
postmarket-surveillance-under-section-522-feder-
al-food-drug-and-cosmetic-act.
13. 21 CFR Part 822.8. Current as of 20 July 2022. FDA
website. https://www.accessdata.fda.gov/scripts/cdrh/
cfdocs/cfcfr/CFRSearch.cfm?fr=822.8.
14. 21 CFR Part 822.10. Current as of 20 July 2022. FDA
website. https://www.accessdata.fda.gov/scripts/cdrh/
cfdocs/cfcfr/CFRSearch.cfm?fr=822.10.
15. 21 CFR 822 Subpart D-FDA Review and Action.
Current as of 20 July 2022. FDA website. https://
www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/
CFRSearch.cfm?CFRPart=822&showFR=1.
16. 21 CFR Part 822.38. Current as of 20 July 2022. FDA
website. https://www.accessdata.fda.gov/scripts/cdrh/
cfdocs/cfcfr/CFRSearch.cfm?fr=822.38.
17. 21 CFR Part 822.20. FDA website. https://www.access-
data.fda.gov/scripts Current as of 20 July 2022. cdrh/
cfdocs/cfcfr/CFRSearch.cfm?fr=822.20.
18. Compliance and Enforcement. Last updated August
2022. FDA website. https://www.fda.gov/animal-veteri-
nary/compliance-enforcement.
19. Criminal Investigations. Last updated July 2022.
FDA website. https://www.fda.gov/inspections-com-
pliance-enforcement-and-criminal-investigations/
criminal-investigations.
20. United States Department of Justice. Freedom of
Information Act (FOIA) website. https://www.foia.
gov/.
21. 21 CFR 803, Medical Device Reporting. Revised
March 2022. FDA website. https://www.accessdata.fda.
gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFR-
Part=803.
22. Medical Devices Device Tracking, Final Rule,
67 FR 5943. 8 February 2002. Federal Register
website. https://www.federalregister.gov/
documents/2002/02/08/02-3076/medical-devices-de-
vice-tracking#:~:text=Current%20section%20519(e)
(,be%20implanted%20in%20the%20human.
23. 21 CFR 803.3. Current as of 20 July 2022. FDA
website. https://www.accessdata.fda.gov/scripts/cdrh/
cfdocs/cfcfr/cfrsearch.cfm?fr=803.3.
24. Information about reporting adverse events
to FDAs MedWatch Program. Last Updated
February 2018. FDA website. https://www.
fda.gov/safety/medwatch-fda-safety-informa-
tion-and-adverse-event-reporting-program/
information-about-reporting-adverse-events-fdas-med-
watch-program.
25. MedWatch Forms for FDA Safety Reporting. Last
updated February 2020. FDA website. https://www.fda.
gov/safety/medical-product-safety-information/med-
watch-forms-fda-safety-reporting.
26. Medical Device Reporting: Electronic Submission
Requirements, Final Rule, 79 FR 8832. 14 February
2014. Federal Register website. https://www.feder-
alregister.gov/documents/2014/02/14/2014-03279/
medical-device-reporting-electronic-submission-re-
quirements.
27. Guidance Document. Questions and Answers
about eMDR-Electronic Medical Device
Reporting: Guidance for Industry, User Facilities,
and FDA Staff. February 2014. Final.FDA
website. https://www.fda.gov/regulatory-in-
formation/search-fda-guidance-documents/
questions-and-answers-about-emdr-electronic-medi-
cal-device-reporting-guidance-industry-user.
28. About Manufacturer and User Facility Device
Experience (MAUDE). Last updated May
2022. FDA website. https://www.fda.gov/
medical-devices/mandatory-reporting-requirements-man-
ufacturers-importers-and-device-user-facilities/
about-manufacturer-and-user-facility-device-experi-
ence-maude.
29. 21 CFR Part 803.19. Current as of 20 July 2022. FDA
website. https://www.accessdata.fda.gov/scripts/cdrh/
cfdocs/cfcfr/CFRSearch.cfm?fr=803.19.