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Regulation of “Biomaterials” and Medical Devices

  • E. Mueller, R. Kammula and D. Marlowe


On May 28, 1976, President Gerald R. Ford signed into law the Medical Device Amendments to the Federal Food, Drug and Cosmetic Act. The purpose of the Amendments is to ensure that medical devices are safe and effective, and properly labelled for their intended use. In order to accomplish this mandate, the Amendments provide the Food and Drug Administration (FDA) with authority to regulate devices during most phases of their development, testing, and use. The FDA's approach to this regulation focuses heavily on both the pre- and post-market phases of a device's lifetime. During the pre-market phase, the FDA concentrates on providing a reasonable assurance that new devices are adequately evaluated for safety and effectiveness. Implicit in this assessment is the concept of balancing risk to benefit. If the benefits significantly outweigh the risks for the intended use, the device will most likely be approved for marketing in the United States. Since risk/benefit assessments for new technology involve considerable clinical judgment, the FDA utilizes expert panels composed of clinicians, engineers, toxicologists, and other experts familiar with the devices. These panels are often directed to review the data provided by the manufacturer to support claims for device safety and effectiveness. If the advisory panel believes the data support the manufacturer's claims, a recommendation for approval for marketing is made to the FDA. The Agency must ultimately decide whether the device is to receive approval for marketing.



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1.Medical Device Amendments of 1976. Federal Food, Drug and Cosmetic Act as Amended and Related Laws. U.S. Government Printing Office, Washington, DC 1990: 0-248-576 QL3.
2.Regulations Establishing Good Manufacturing Practices for the Manufacture, Packing, Storage, and Installation of Medical Devices.” Federal Register (43 FR 31508) July 21, 1978.
3.FDA Guidance Documents for assessing new medical device safety and effectiveness can be obtained from an FDA-operated electronic bulletin board in Rockville, Maryland. EBBS operates 24 hours per day and can be accessed by modem at (301) 4437496.
4.Toxicology Subgroup Tripartite Subcommittee on Medical Devices (1986), Tripartite Biocompatibility Guidance for Medical Devices, Washington, DC, U.S. Department of Health and Human Services.
5.West, D.L., J. Amer. College of Toxicology 7 (4) (1988) p. 499.
6.Biological Testing of Medical and Dental Materials and Devices, Part 1: Guidance on Selection of Tests. ISO Draft International Standard 10993-1.
7.Good Laboratory Practices (GLP) Regulations.” Federal Register (52 FR 33768) September 4, 1987.
8.Safe Medical Devices Act of 1990. Conference Report, House of Representatives. Report #101-959 (1990).


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