The Medical Device Validation Handbook
171
References
1. 21 CFR Part 830, Unique Device Identification.
Current as of 29 June 2023. Accessed 3 July 2023.
https://www.ecfr.gov/current/title-21/chapter-I/sub-
chapter-H/part-830
2. Food and Drug Administration. Unique Device
Identification (UDI) website. Last updated 22 July
2022. Accessed 3 July 2023. http://www.fda.gov/
MedicalDevices/DeviceRegulationandGuidance/
UniqueDeviceIdentification/default.htm
3. Food and Drug Administration. Global Unique
Device Identification Database [guidance]. Current
as of 5 February 2018. Accessed 3 July 2023.
https://www.fda.gov/regulatory-information/
search-fda-guidance-documents/global-unique-de-
vice-identification-database-gudid
4. Food and Drug Administration. Global
Unique Device Identification Database
(GUDID) website. Last updated 7 June 2023.
Accessed 3 July 2023. http://www.fda.gov/
MedicalDevices/DeviceRegulationandGuidance/
UniqueDeviceIdentification/
GlobalUDIDatabaseGUDID/default.htm
5. 21 CFR Part 801, Labeling. Current as of 18 December
1978. Current as of 3 July 2023. https://www.ecfr.gov/
current/title-21/chapter-I/subchapter-H/part-801
6. 21 CFR Part 820, Quality System Regulation. Current
as of 7 June 2023. Accessed 3 July 2023. https://
www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/
CFRSearch.cfm?CFRPart=820
7. Global Medical Device Nomenclature (GMDN)
Agency website. Accessed 3 July 2023. https://www.
gmdnagency.org/
8. Food and Drug Administration. Part 11, Electronic
records Electronic signatures—scope and application
[guidance]. Current as of 24 August 2018. Accessed 3
July 2023. https://www.fda.gov/regulatory-information/
search-fda-guidance-documents/part-11-electronic-re-
cords-electronic-signatures-scope-and-application
9. Global Harmonization Task Force. Quality manage-
ment systems—process validation guidance (2nd ed.)
Dated January 2004. Accessed 3 July 2023. https://
www.imdrf.org/sites/default/files/docs/ghtf/final/sg3/
technical-docs/ghtf-sg3-n99-10-2004-qms-process-
guidance-04010.pdf
10. Association for Automatic Identification and Mobility.
The layman’s guide to ANSI, CEN, and ISO bar
code print quality documents. Dated November
2002. Accessed 3 July 2023. https://assets.omron.eu/
downloads/manual/en/v2/the_layman_s_guide_to_
ansi,_cen_and_iso_iec_linear_bar_code_print_qual-
ity_documents_users_manual_en.pdf
11. Food and Drug Administration. General principles of
software validation [guidance]. Current as of 15 May
2019. Accessed 3 July 2023. https://www.fda.gov/reg-
ulatory-information/search-fda-guidance-documents/
general-principles-software-validation
171
References
1. 21 CFR Part 830, Unique Device Identification.
Current as of 29 June 2023. Accessed 3 July 2023.
https://www.ecfr.gov/current/title-21/chapter-I/sub-
chapter-H/part-830
2. Food and Drug Administration. Unique Device
Identification (UDI) website. Last updated 22 July
2022. Accessed 3 July 2023. http://www.fda.gov/
MedicalDevices/DeviceRegulationandGuidance/
UniqueDeviceIdentification/default.htm
3. Food and Drug Administration. Global Unique
Device Identification Database [guidance]. Current
as of 5 February 2018. Accessed 3 July 2023.
https://www.fda.gov/regulatory-information/
search-fda-guidance-documents/global-unique-de-
vice-identification-database-gudid
4. Food and Drug Administration. Global
Unique Device Identification Database
(GUDID) website. Last updated 7 June 2023.
Accessed 3 July 2023. http://www.fda.gov/
MedicalDevices/DeviceRegulationandGuidance/
UniqueDeviceIdentification/
GlobalUDIDatabaseGUDID/default.htm
5. 21 CFR Part 801, Labeling. Current as of 18 December
1978. Current as of 3 July 2023. https://www.ecfr.gov/
current/title-21/chapter-I/subchapter-H/part-801
6. 21 CFR Part 820, Quality System Regulation. Current
as of 7 June 2023. Accessed 3 July 2023. https://
www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/
CFRSearch.cfm?CFRPart=820
7. Global Medical Device Nomenclature (GMDN)
Agency website. Accessed 3 July 2023. https://www.
gmdnagency.org/
8. Food and Drug Administration. Part 11, Electronic
records Electronic signatures—scope and application
[guidance]. Current as of 24 August 2018. Accessed 3
July 2023. https://www.fda.gov/regulatory-information/
search-fda-guidance-documents/part-11-electronic-re-
cords-electronic-signatures-scope-and-application
9. Global Harmonization Task Force. Quality manage-
ment systems—process validation guidance (2nd ed.)
Dated January 2004. Accessed 3 July 2023. https://
www.imdrf.org/sites/default/files/docs/ghtf/final/sg3/
technical-docs/ghtf-sg3-n99-10-2004-qms-process-
guidance-04010.pdf
10. Association for Automatic Identification and Mobility.
The layman’s guide to ANSI, CEN, and ISO bar
code print quality documents. Dated November
2002. Accessed 3 July 2023. https://assets.omron.eu/
downloads/manual/en/v2/the_layman_s_guide_to_
ansi,_cen_and_iso_iec_linear_bar_code_print_qual-
ity_documents_users_manual_en.pdf
11. Food and Drug Administration. General principles of
software validation [guidance]. Current as of 15 May
2019. Accessed 3 July 2023. https://www.fda.gov/reg-
ulatory-information/search-fda-guidance-documents/
general-principles-software-validation