Introduction: History and Where We Are Headed

  • Shayne C. GadEmail author


While medical devices have been derived and used since at least ancient Egypt, means of verifying their biologic safety to patients (biocompatibility) and regulations requiring and governing such pre-use evaluation (testing) are much more recent. Less than a century has seen the modern approach, with testing dictated by type, and duration, of patient contact are much more recent. Such requirements first arise in the 1960s due to concerns with materials migrated from a device into the patient body. The science and complexity of testing involved are continuously evolving (accelerated by concerns as to the safety of silicones in the late 1980’s) and have also served to drive the growth of the medical device market (now nearly a third the size of the pharmaceutical market) and the innovations and complexity of devices and device/drug combinations.


Adverse effects on patients Biocompatibility Biodegradation of material or device Breast implants Center for Devices and Radiological Health Constituent materials in the device Cooper Committee Cumulative duration of contact Dalkon Shield Dr. John Autian Food, Drug, and Cosmetic Act IDE Leachables Medical Device Amendments Medical device industry Patient contact mode and duration Patient exposure parameters Safe Medical Devices Act Tripartite 


  1. APHIS. (1989). Animal and Plant Health Inspection Service, United States Department of Agriculture. Federal Register, 54(168), 36112–36163.Google Scholar
  2. ASTM. (1990). Standardization in Europe: A success story. ASTM Standardization News, 38, February 1990, pp. 1–4.Google Scholar
  3. Boutrand, J.-P. (Ed.). (2012). Biocompatibility and performance of medical devices. Cambridge: Woodhead Publishing.Google Scholar
  4. Calley, D., Autian, J., & Guess, W. L. (1966). Toxicology of a series of phthalate esters. Journal of Pharmaceutical Sciences, 55(2), 158–162.CrossRefGoogle Scholar
  5. CDRH. (1992). Regulatory requirements for medical devices: A workshop manual. Rockville: Center for Device and Radiological Health, HHS Publication FDA 92–4165.Google Scholar
  6. CFR. (1992). FDA’s policy statement concerning cooperative manufacturing arrangements for licensed biologics. Federal Register, 57, 55544.Google Scholar
  7. Di Silvio, L. (Ed.). (2009). Cellular response to biomaterials. Cambridge: Woodhead Publishing.Google Scholar
  8. European Committee for Standardization. (1991). CEN Annual Report 1991. Brussels.Google Scholar
  9. FAO. (1991). Report of the FAO/WHO Conference on Food Standards, Chemicals in Food and Food Trade (in cooperation with GATT), Vol. 1, Rome, March 18–27.Google Scholar
  10. FDA. (2016). ISO 10993-1. Biological evaluation of medical devices. Part1: Evaluation and testing within a risk management process. Department of Health and Human Services. Silver Springs, MD.Google Scholar
  11. FDA. (1986). Tripartite biocompatibility guidance for medical devices. Rockville: Toxicology Subgroup of the Tripartite Sub-Committee on Medical Devices, Food and Drug Administration, Center for Devices and Radiological Health (FDA CDRH).Google Scholar
  12. FDA. (2013). Good laboratory practice regulations: 21 CFR 58.158.219.Google Scholar
  13. FDLI. (2013). Compilation of food and drug Laws, volumes I, II, III and supplement. Washington, D.C.: Food and Drug Law Institute.Google Scholar
  14. Gad, S. C. (2001). Regulatory toxicology (2nd ed.). Philadelphia: Taylor & Francis.CrossRefGoogle Scholar
  15. Gad, S. C., & Chengelis, C. P. (Eds.) (1992) Animals Models in Toxicology. Marcel Dekker, New York. p. 884.Google Scholar
  16. Gad, S. C., & Gad-McDonald, S. E. (2015). Biomaterials, medical devices, and combination products: Biocompatibility testing and safety assessment. Boca Raton: CRC Press.CrossRefGoogle Scholar
  17. Gad, S. C., & Schuh, J. C. L. (2018). Points to consider for toxicologic pathologists evaluating biomaterials and medical devices. Toxicologic Pathology, 46(4), 366–371.CrossRefGoogle Scholar
  18. Gad, S. C., & Taulbee, S. (1996). Handbook of data recording, maintenance and management for the biomedical sciences. Boca Raton: CRC Press.Google Scholar
  19. Greco, R. S. (1994). Implantation biology: The host response and biomedical devices. Boca Raton: CRC Press.Google Scholar
  20. Hutt, P. B. (1989). A history of government regulation and misbranding of medical devices. Food Drug Cosmetic Law Journal, 44(2), 99–117.Google Scholar
  21. ISO. (1990). ISO 9000 international standards for quality management vision 2000—A strategy for international standards’ implementation in the quality arena during the 1990s (2nd ed., compendium). Brussels: EEC.Google Scholar
  22. Lang, L. A. (1996). A review of latex hypersensitivity. Toxic Substance Mechanisms, 15, 1–11.Google Scholar
  23. Lewis, R. J. (2012) SAX’S Dangerous Properties of Industrial Materials, 12th Ed., Wiley-Interscience, Hoboken, NJ.Google Scholar
  24. MAPI. (1992). The European community’s new approach to regulation of product standards and quality assurance (ISO 9000): What it means for U.S. manufacturers. MAPI Economic Report ER-218.Google Scholar
  25. MDDI. (2013). Industry snapshot. Medical Device & Diagnostics Industry, July 2013, 52–62.Google Scholar
  26. Nocera, J. (1995). Fatal litigation. Fortune, October 23, 1995, 60–82.Google Scholar
  27. Nugent, T. N. (1994). Health care products & services basic analysis. New York: Standard & Poor’s Industry Surveys.Google Scholar
  28. O’Grady, J. (1990). Interview with Charles M. Ludolph. ASTM Standardization News, 26, February, 1990, pp. 3–6.Google Scholar
  29. Regulatory Affairs Focus. (1996). European update. Regulatory Affairs Focus, 1(4), 8.Google Scholar
  30. Sivin, I. (1993). Another look at the Dalkon Shield: Meta-analysis underscores the problems. Contraception, 48, 1–12.CrossRefGoogle Scholar
  31. Spizizen, G. (1992). The ISO 9000 standards: Creating a level playing field for international quality. National Productivity Review, 11(3), 331–346.CrossRefGoogle Scholar
  32. The Wilkerson Group. (2013). Forces reshaping the performance and contribution of the U.S. medical device industry. Washington, D.C.: Health Industry Manufacturers Association.Google Scholar
  33. USP. (2006). The United States pharmacopoeia <88>, biological reactivity tests, in vivo, USP 29. Rockville: United States Pharmacopoeial Convention.Google Scholar
  34. USP. (2013). The United States pharmacopoeia, 36 revision. Rockville: United States Pharmacopoeial Convention.Google Scholar

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© Springer Nature Switzerland AG 2019

Authors and Affiliations

  1. 1.Gad Consulting ServicesRaleighUSA

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