Research Involving Medical Devices

  • Mary Kay Ryan


Unlike the history of drug regulation within the United States, there seems to be no single, major incident to which one can attribute the genesis of medical device regulation. While there is a history of product failures and recall of devices having potentially serious consequences (Beck, 1979b), the impetus behind government regulation of medical devices seems to have been the increasing complexity of medical technology, the number of new therapeutic and diagnostic devices entering the market, and the general regulatory atmosphere prevalent in the United States. The intent has been to prevent a “thalidomide” in the world of medical devices.


Medical Device Clinical Investigator Versus Versus Versus Versus Versus Knee Brace Tongue Depressor 
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  1. Beck, W. C, 1979a, The physician’s role in the quality control of medical devices, J. Am. Med. Assoc. 241:56–57.CrossRefGoogle Scholar
  2. Beck, W. C, 1979b, The surgeon’s role in device standardization, Am. J. Surg. 137:149–151.CrossRefGoogle Scholar
  3. Brown, J. H. U., 1976, Medical devices as medical problems: The regulation of devices for clinical use, Biomed. Eng. 11:337–339.Google Scholar
  4. Clark, R. E., 1980, Medical device regulation: Current and future trends, Ann. Thorac. Surg., 29:298–299.CrossRefGoogle Scholar
  5. Clark, R. E., 1979, Federal regulation and the practicing surgeon, Am. J. Surg. 138:775–778.CrossRefGoogle Scholar
  6. Covelli, P., 1981, New hope for diabetics, The New York Times Magazine 1981(March 8):62–70.Google Scholar
  7. Dobelle, W. H., 1977, Minimizing the adverse effects of the medical device amendments of 1976 on innovation in artificial organs research, Artific. Organs 1:65–75.CrossRefGoogle Scholar
  8. Frisch, E., 1980, An economic evaluation of premarket regulatory requirements, Med. Devices Diagnostic Industry 2:31–38.Google Scholar
  9. Gildenberg, P., 1980, Neurosurgical devices and drugs, Neurosurgery 6:220–223.CrossRefGoogle Scholar
  10. Hoffman, F., 1979, Has the FDA provided the best possible solution? Man Med. 4:198–200.Google Scholar
  11. Holder, A., 1980, FDA’s final regulations: IRBs and medical devices, IRB: A Review of Human Subjects Research 2(6):1–4.Google Scholar
  12. Mannisto, M., 1980, Public press focuses on advances in medical research/technology, Hospitals 1980(December 16):65–68.Google Scholar
  13. Reiser, S. J., 1979, Striking a balance, Man Med. 4:201–202.Google Scholar
  14. Vladeck, B. C, 1979, Regulation and innovation, Man Med. 4:203–204.Google Scholar

Copyright information

© Plenum Press, New York 1982

Authors and Affiliations

  • Mary Kay Ryan
    • 1
  1. 1.Long Island Jewish-Hillside Medical CenterNew Hyde ParkUSA

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