238
Chapter 15: Use of Standards in Medical Device Global Regulatory Strategy
7. International Electrotechnical Commission website.
http://www.iec.ch/. Accessed 13 July 2020.
8. CLSI Homepage. CLSI website. http://clsi.org/
about-clsi/. Accessed 13 July 2020.
9. Underwriters Laboratories (UL) website. https://
ul.org/. Accessed 17 July 2020.
10. ANSI as American National Standards. AAMI also
administers a number of international ISO and IEC
technical committees as well as US TAGs.
11. ASTM International website. https://www.astm.org/
ABOUT/overview.html. Accessed 13 July 2020.
12. AHWP Homepage. AHWP website. http://www.
ahwp.info/. Accessed 13 July 2020.
13. Representatives of Member Economies. AHWP
website. http://www.ahwp.info/index.php?q=node/80.
Accessed 13 July 2020.
14. GHTF Final Documents. IMDRF website. http://
imdrf.org/documents/documents.asp#ghtf. Accessed
13 July 2020.
15. TGA Homepage. TGA website. http://www.tga.gov.
au/. Accessed 13 July 2020.
16. ISO 13485:2003, Section 0.1 General. Medical
Devices—Quality Management Systems—Requirements
for Regulatory Purposes. ISO website. http://www.iso.
org/iso/catalogue_detail?csnumber=36786. Accessed
13 July 2020.
17. “What is the relationship between FDA’s Quality
System Regulation for Devices, Part 820 and ISO
9001: 2000?” FDA website. http://www.fda.gov/down-
loads/Medica...itySystemsRegulations/UCM134625.
pdf. Accessed 13 July 2020.
18. Quality System (QS) Regulation/Medical Device Good
Manufacturing Practices. FDA website. http://www.fda.
gov/MedicalDevices/DeviceRegulationandGuidance/
PostmarketRequirements/
QualitySystemsRegulations/. Accessed 13 July 2020.
19. “FDA Will Transition from 21 CFR 820 QSR to
ISO 13485:2016 for Medical Device Quality Systems
Audit Inspections in the Near Future.” April 2019.
Thomas Regulatory Resolutions website. https://www.
thomasregulatory.com/l/fda-rule-change-from-21-cfr-
820-to-iso-13485-2016-harmonization-for-quality-
systems-and-audits/#. Accessed 16 July 2020.
20. EN ISO 14971:2012 Medical Devices—Quality
Management Systems—Requirements for Regulatory
Purposes.
21. IEC 62366:2014 Medical Devices—Application of
Usability Engineering to Medical Devices. ANSI
website. http://webstore.ansi.org/RecordDetail.
aspx?sku=IEC%2062366%20Ed.%201.1%20
b:2014&source=google&adgroup=iec&gclid=C-
Ji7n6Tv-MoCFdAWHwodh3QDVA. Accessed 13
July 2020.
22. Standards (Medical Devices). FDA web-
site. http://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/Standards/default.
htm. Accessed 13 July 2020.
23. CDRH Standard Operating Procedures for Identification
of Candidate Consensus Standards for Recognition.
FDA website. http://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/GuidanceDocuments/
ucm077307.htm. Accessed 13 July 2020.
24. Appropriate Use of Voluntary Consensus Standards in
Premarket Submissions for Medical Devices. Guidance
for Industry and Food and Drug Administration Staff.
September 2018. FDA website. https://www.fda.gov/
regulatory-information/search-fda-guidance-docu-
ments/appropriate-use-voluntary-consensus-stan-
dards-premarket-submissions-medical-devices.
Accessed 13 July 2020.
25. Accreditation Scheme for Conformity Assessment
(ASCA). FDA website. https://www.fda.gov/
medical-devices/standards-and-conformity-assess-
ment-program/accreditation-scheme-conformity-as-
sessment-asca. Accessed 13 July 2020.
26. Guidance for Industry and Food and Drug
Administration Staff. Frequently Asked Questions
on Recognition of Consensus Standards. FDA
website. http://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/GuidanceDocuments/
ucm074973.htm. Accessed 13 July 2020.
27. Use of International Standard ISO-10993, “Biological
Evaluation of Medical Devices Part 1: Evaluation and
Testing” (Replaces #G87-1 #8294) (blue book memo)
(Text Only). FDA website. http://www.fda.gov/
MedicalDevices/DeviceRegulationandGuidance/
GuidanceDocuments/ucm080735.htm. Accessed 13
July 2020.
28. Code of Federal Regulations, Title 21, Part 870,
Subpart D, Sec. 870.3925, Replacement heart valve.
FDA website. https://www.accessdata.fda.gov/scripts/
cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=870.3925. Accessed
13 July 2020.
29. EU Medical Devices Directive (93/42/EEC, MDD).
EUR-Lex website. https://eur-lex.europa.eu/le-
gal-content/EN/TXT/?uri=CELEX:31993L0042.
Accessed 13 July 2020.
30. The Bjork-Shiley Convexo-Concave Heart Valve was
removed from the US market in November 1986. See
also Bjork-Shiley Heart Valve Recall. Major Recalls
of Organ Replacement Devices. Brown University
website. http://biomed.brown.edu/Courses/BI108/
BI108_2007_Groups/group05/pages/bjork_shiley.
html. Accessed 13 July 2020.
31. Samuel FE Jr. Safe Medical Devices Act of 1990. Health
Affairs, 10, no.1 (1991):192–195. Health Affairs web-
site. http://content.healthaffairs.org/content/10/1/192.
short. Accessed 13 July 2020.
32. Draft Guidance for Industry and FDA Staff, Heart
Valves—Investigational Device Exemption (IDE) and
Premarket Approval (PMA) Applications in 1994.
33. Investigational Device Exemptions (IDE’s) for Early
Feasibility Medical Device Clinical Studies, Including
First in Human (FIH) Studies, Guidance for Industry
and Food and Drug Administration Staff, Document
issued 1 October 2013. FDA website. http://www.
fda.gov/downloads/medicaldevices/deviceregulation-
andguidance/guidancedocuments/ucm279103.pdf.
Accessed 13 July 2020.
34. ISO 5830-2:2015 Cardiovascular Implants—Cardiac
Valve Prostheses—Part 2: Surgically Implanted Heart
Valve Substitutes. ISO webisite. https://www.iso.org/
standard/51314.html. Accessed 17 July 2020.
Chapter 15: Use of Standards in Medical Device Global Regulatory Strategy
7. International Electrotechnical Commission website.
http://www.iec.ch/. Accessed 13 July 2020.
8. CLSI Homepage. CLSI website. http://clsi.org/
about-clsi/. Accessed 13 July 2020.
9. Underwriters Laboratories (UL) website. https://
ul.org/. Accessed 17 July 2020.
10. ANSI as American National Standards. AAMI also
administers a number of international ISO and IEC
technical committees as well as US TAGs.
11. ASTM International website. https://www.astm.org/
ABOUT/overview.html. Accessed 13 July 2020.
12. AHWP Homepage. AHWP website. http://www.
ahwp.info/. Accessed 13 July 2020.
13. Representatives of Member Economies. AHWP
website. http://www.ahwp.info/index.php?q=node/80.
Accessed 13 July 2020.
14. GHTF Final Documents. IMDRF website. http://
imdrf.org/documents/documents.asp#ghtf. Accessed
13 July 2020.
15. TGA Homepage. TGA website. http://www.tga.gov.
au/. Accessed 13 July 2020.
16. ISO 13485:2003, Section 0.1 General. Medical
Devices—Quality Management Systems—Requirements
for Regulatory Purposes. ISO website. http://www.iso.
org/iso/catalogue_detail?csnumber=36786. Accessed
13 July 2020.
17. “What is the relationship between FDA’s Quality
System Regulation for Devices, Part 820 and ISO
9001: 2000?” FDA website. http://www.fda.gov/down-
loads/Medica...itySystemsRegulations/UCM134625.
pdf. Accessed 13 July 2020.
18. Quality System (QS) Regulation/Medical Device Good
Manufacturing Practices. FDA website. http://www.fda.
gov/MedicalDevices/DeviceRegulationandGuidance/
PostmarketRequirements/
QualitySystemsRegulations/. Accessed 13 July 2020.
19. “FDA Will Transition from 21 CFR 820 QSR to
ISO 13485:2016 for Medical Device Quality Systems
Audit Inspections in the Near Future.” April 2019.
Thomas Regulatory Resolutions website. https://www.
thomasregulatory.com/l/fda-rule-change-from-21-cfr-
820-to-iso-13485-2016-harmonization-for-quality-
systems-and-audits/#. Accessed 16 July 2020.
20. EN ISO 14971:2012 Medical Devices—Quality
Management Systems—Requirements for Regulatory
Purposes.
21. IEC 62366:2014 Medical Devices—Application of
Usability Engineering to Medical Devices. ANSI
website. http://webstore.ansi.org/RecordDetail.
aspx?sku=IEC%2062366%20Ed.%201.1%20
b:2014&source=google&adgroup=iec&gclid=C-
Ji7n6Tv-MoCFdAWHwodh3QDVA. Accessed 13
July 2020.
22. Standards (Medical Devices). FDA web-
site. http://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/Standards/default.
htm. Accessed 13 July 2020.
23. CDRH Standard Operating Procedures for Identification
of Candidate Consensus Standards for Recognition.
FDA website. http://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/GuidanceDocuments/
ucm077307.htm. Accessed 13 July 2020.
24. Appropriate Use of Voluntary Consensus Standards in
Premarket Submissions for Medical Devices. Guidance
for Industry and Food and Drug Administration Staff.
September 2018. FDA website. https://www.fda.gov/
regulatory-information/search-fda-guidance-docu-
ments/appropriate-use-voluntary-consensus-stan-
dards-premarket-submissions-medical-devices.
Accessed 13 July 2020.
25. Accreditation Scheme for Conformity Assessment
(ASCA). FDA website. https://www.fda.gov/
medical-devices/standards-and-conformity-assess-
ment-program/accreditation-scheme-conformity-as-
sessment-asca. Accessed 13 July 2020.
26. Guidance for Industry and Food and Drug
Administration Staff. Frequently Asked Questions
on Recognition of Consensus Standards. FDA
website. http://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/GuidanceDocuments/
ucm074973.htm. Accessed 13 July 2020.
27. Use of International Standard ISO-10993, “Biological
Evaluation of Medical Devices Part 1: Evaluation and
Testing” (Replaces #G87-1 #8294) (blue book memo)
(Text Only). FDA website. http://www.fda.gov/
MedicalDevices/DeviceRegulationandGuidance/
GuidanceDocuments/ucm080735.htm. Accessed 13
July 2020.
28. Code of Federal Regulations, Title 21, Part 870,
Subpart D, Sec. 870.3925, Replacement heart valve.
FDA website. https://www.accessdata.fda.gov/scripts/
cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=870.3925. Accessed
13 July 2020.
29. EU Medical Devices Directive (93/42/EEC, MDD).
EUR-Lex website. https://eur-lex.europa.eu/le-
gal-content/EN/TXT/?uri=CELEX:31993L0042.
Accessed 13 July 2020.
30. The Bjork-Shiley Convexo-Concave Heart Valve was
removed from the US market in November 1986. See
also Bjork-Shiley Heart Valve Recall. Major Recalls
of Organ Replacement Devices. Brown University
website. http://biomed.brown.edu/Courses/BI108/
BI108_2007_Groups/group05/pages/bjork_shiley.
html. Accessed 13 July 2020.
31. Samuel FE Jr. Safe Medical Devices Act of 1990. Health
Affairs, 10, no.1 (1991):192–195. Health Affairs web-
site. http://content.healthaffairs.org/content/10/1/192.
short. Accessed 13 July 2020.
32. Draft Guidance for Industry and FDA Staff, Heart
Valves—Investigational Device Exemption (IDE) and
Premarket Approval (PMA) Applications in 1994.
33. Investigational Device Exemptions (IDE’s) for Early
Feasibility Medical Device Clinical Studies, Including
First in Human (FIH) Studies, Guidance for Industry
and Food and Drug Administration Staff, Document
issued 1 October 2013. FDA website. http://www.
fda.gov/downloads/medicaldevices/deviceregulation-
andguidance/guidancedocuments/ucm279103.pdf.
Accessed 13 July 2020.
34. ISO 5830-2:2015 Cardiovascular Implants—Cardiac
Valve Prostheses—Part 2: Surgically Implanted Heart
Valve Substitutes. ISO webisite. https://www.iso.org/
standard/51314.html. Accessed 17 July 2020.