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Medical Devices: A History
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medical-devices-in-the-uk
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35. European Commission. Safety of Poly Implant Prothèse (PIP) Silicone
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implant-prothese-pip-silicone-breast-implants-2013-update_en
36. Regulation (EU) 2017/745 of the European Parliament and of the
Council of 5 April 2017 on medical devices, amending Directive
2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No
1223/2009 and repealing Council Directives 90/385/EEC and 93/42/
EEC. Published 5 April 2017. Accessed 26 June 2024. https://eur-lex.
europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0745
37. Regulation (EU) 2017/746 of the European Parliament and of the
Council of 5 April 2017 on in vitro diagnostic medical devices and
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EU. Accessed 26 June 2024. https://eur-lex.europa.eu/legal-content/
EN/TXT/PDF/?uri=CELEX:32017R0746
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39. Directive 98/34/EC of the European Parliament and of the Council of
22 June 1998 laying down a procedure for the provision of information
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dir/1998/34/oj/eng
40. Regulation (EU) No 1025/2012 of the European Parliament and of the
Council of 25 October 2012 on European standardisation, amending
Council Directives 89/686/EEC and 93/15/EEC and Directives
94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/
EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European
Parliament and of the Council and repealing Council Decision 87/95/
EEC and Decision No 1673/2006/EC of the European Parliament and
of the Council. Published 25 October 2012. Accessed 24 March 2025.
https://eur-lex.europa.eu/eli/reg/2012/1025/oj/eng
41. European Commission: Directorate-General for Enterprise and
Industry. Publications Office of the European Union. Guide to the
implementation of directives based on the new approach and the global
CHAPTER 1:
Medical Devices: A History
fda/published/The-Sulfanilamide-Disaster.pdf
13. Food and Drug Administration. CDRH milestones. Updated 9
January 2006. Accessed 16 February 2024. https://www.fda.gov/
media/108643/download
14. Medical Devices Amendment. Public Law 94-295. 28 May 1976.
Accessed 14 March 2025. https://www.govinfo.gov/content/pkg/
STATUTE-90/pdf/STATUTE-90-Pg539.pdf
15. Food and Drug Administration. A history of medical device regulation
and oversight in the United States. Current as of 21 August 2023.
Accessed 16 February 2024. https://www.fda.gov/medical-devices/
overview-device-regulation/history-medical-device-regulation-
oversight-united-states
16. Food and Drug Administration. The least burdensome provisions:
concepts and principles [guidance]. Issued on 5 February 2019. Accessed
18 February 2024. https://www.fda.gov/media/73188/download
17. Food and Drug Administration Modernization Act of 1997, S.830.
105th cong. Accessed 18 February 2024. https://www.govinfo.gov/
content/pkg/PLAW-105publ115/pdf/PLAW-105publ115.pdf
18. Food and Drug Administration. De Novo program – transcript.
Current as of 4 January 2018. Accessed 18 February 2024. https://
www.fda.gov/training-and-continuing-education/cdrh-learn/de-novo-
program-transcript
19. Food and Drug Administration. Medical Device User Fee
Amendments (MDUFA). Current as of 3 October 2024. Accessed 5
March 2025. https://www.fda.gov/industry/fda-user-fee-programs/
medical-device-user-fee-amendments-mdufa
20. Food and Drug Administration Safety and Innovation Act (FDASIA).
Current as of 28 March 2018. Accessed 14 March 2025. https://www.
fda.gov/regulatory-information/selected-amendments-fdc-act/food-
and-drug-administration-safety-and-innovation-act-fdasia
21. Center for Devices and Radiological Health. Food and Drug
Administration. Current as of 24 January 2024. Accessed 14 March
2025.
22. Forsey EA. How Canadians Govern Themselves. 10th ed. Her Majesty
the Queen in Right of Canada, as represented by the Minister of
Public Works 2020. Verified 5 March 2025.
23. The Canadian Encyclopedia. Health Canada. Last updated 04 August
2014. Accessed 24 March 2025. https://www.thecanadianencyclopedia.
ca/en/article/health-canada
24. R.S.C., 1985, c. F-27. Food and Drugs Act. Current as of 24 March
2025. Accessed 24 March 2025. https://laws-lois.justice.gc.ca/eng/
acts/F-27/SOR/98-282.
25. SOR/98-282. Medical devices regulations. Current as of 24 March
2025. Accessed 24 March 2025. Accessed 24 March 2025. https://
laws-lois.justice.gc.ca/eng/regulations/sor-98-282/
26. Health Canada. Quality Systems ISO 13485. Last updated 1 February
2019. Accessed 24 March 2025. https://www.canada.ca/en/health-
canada/services/drugs-health-products/medical-devices/quality-
systems-13485.html
27. Health Canada. Transition to Medical Device Single Audit Program.
Last updated 11 October 2018. Accessed 24 March 2025. https://
www.canada.ca/en/health-canada/services/drugs-health-products/
medical-devices/activities/international/transition-medical-device-
single-audit-program.html
28. European Parliament. Treaty of Rome. Accessed 24 March 2025.
https://www.europarl.europa.eu/about-parliament/en/in-the-past/the-
parliament-and-the-treaties/treaty-of-rome
29. Council Resolution of 7 May 1985 on a new approach to technical
harmonization and standards. Current as of 7 May 1985. Accessed
March 2025. https://eur-lex.europa.eu/legal-content/BG/
TXT/?uri=CELEX:31985Y0604(01)
30. Official Journal of the European Union. Accessed 5 March 2025
https://eur-lex.europa.eu/oj/direct-access.html
31. Medicines and Healthcare products Regulatory Agency (MHRA).
Regulating medical devices in the UK. Last updated 17 February 2025.
Accessed 24 March 2025. https://www.gov.uk/guidance/regulating-
medical-devices-in-the-uk
32. European Commission. Medical Devices – Sector. Accessed 5 March
2025. https://health.ec.europa.eu/medical-devices-sector_en
33. European Commission. Single Market Compliance Space. Accessed
24 March 2025. https://webgate.ec.europa.eu/single-market-
compliance-space/#/notified-bodies
34. The Nuremberg Code. BMJ. 1996 313(7070):1448. CIRP website.
Accessed 24 March 2025. http://www.cirp.org/library/ethics/nuremberg
35. European Commission. Safety of Poly Implant Prothèse (PIP) Silicone
Breast Implants (2013 update). Published 12 May 2014. Accessed 24
March 2025. https://health.ec.europa.eu/publications/safety-poly-
implant-prothese-pip-silicone-breast-implants-2013-update_en
36. Regulation (EU) 2017/745 of the European Parliament and of the
Council of 5 April 2017 on medical devices, amending Directive
2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No
1223/2009 and repealing Council Directives 90/385/EEC and 93/42/
EEC. Published 5 April 2017. Accessed 26 June 2024. https://eur-lex.
europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0745
37. Regulation (EU) 2017/746 of the European Parliament and of the
Council of 5 April 2017 on in vitro diagnostic medical devices and
repealing Directive 98/79/ EC and Commission Decision 2010/227/
EU. Accessed 26 June 2024. https://eur-lex.europa.eu/legal-content/
EN/TXT/PDF/?uri=CELEX:32017R0746
38. Council Directive 83/189/EEC of 28 March 1983 laying down a
procedure for the provision of information in the field of technical
standards and regulations. Published 28 March 1983. Accessed 24
March 2025. https://eur-lex.europa.eu/eli/dir/1983/189/oj/eng
39. Directive 98/34/EC of the European Parliament and of the Council of
22 June 1998 laying down a procedure for the provision of information
in the field of technical standards and regulations. Published 22
June 1998. Accessed 24 March 2025. https://eur-lex.europa.eu/eli/
dir/1998/34/oj/eng
40. Regulation (EU) No 1025/2012 of the European Parliament and of the
Council of 25 October 2012 on European standardisation, amending
Council Directives 89/686/EEC and 93/15/EEC and Directives
94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/
EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European
Parliament and of the Council and repealing Council Decision 87/95/
EEC and Decision No 1673/2006/EC of the European Parliament and
of the Council. Published 25 October 2012. Accessed 24 March 2025.
https://eur-lex.europa.eu/eli/reg/2012/1025/oj/eng
41. European Commission: Directorate-General for Enterprise and
Industry. Publications Office of the European Union. Guide to the
implementation of directives based on the new approach and the global