Medical Device Regulation Act

History

During the 1960s, the Secretary of Health, Education, and Welfare (HEW) commissioned the Cooper Committee to study the adverse effects of medical devices for human use. In 1970, the study committee recommended a classification for medical devices based on comparative risk. In 1976, the Dalkon Shield intrauterine device injured at least 900,000 women in the United States, which aided the emphasis for regulatory oversight and therapeutic requirements provided by the U.S. legislation P.L. 94-295.

Provisions of the Act

Classification of Medical Devices

There are three classifications for medical devices: :* Class I - General Controls for devices considered as low risks for human use.

:* Class II - Performance Standards for devices considered as moderate risks for human use.

:* Class III - Premarket Approval for devices considered as high risks for human use.

Classification Panels for Medical Devices

:* Classification panels are to determine which devices intended for human use should be subject to the requirements of class I - general controls, class II - performance standards, or class III - premarket approval. :* Classification panels are to provide notice to the manufacturers and importers of medical devices intended for human use. :* Manufacturers and importers are to prepare for the application of such requirements and to report medical devices intended for human use manufactured or imported by them. :* Panel appointments shall consist of members with adequately diversified expertise in such fields as biological and physical sciences, clinical and administrative medicine, engineering, and other related professions. Persons who are qualified by training and experience to evaluate the safety and effectiveness of medical devices or possess skills in the use of, experience in the development, manufacture, or utilization of such medical devices. :* No individual who is in the regular full-time employment of the United States and engaged in the administration of this Act may be a member of any medical device classification panel.

References

References

1. 94th U.S. Congress. (December 11, 1975). "H.R.11124: Medical Device Amendments". Library of Congress THOMAS.
2. 94th U.S. Congress. (May 28, 1976). "S.510: An Act to amend the Federal Food, Drug, and Cosmetic Act to provide for the safety and effectiveness of medical devices intended for human use, and for other purposes.".
3. "Gerald R. Ford: "Statement on Signing the Medical Device Amendments of 1976.," May 28, 1976". University of California - Santa Barbara.
4. Office of the Federal Register. "Federal Food, Drug, and Cosmestic Act of June 25, 1938, Public Law 75-717, 52 Stat 1040". U.S. National Archives and Records Administration.
5. Rados, Carol. (January–February 2006). "The Medical Device Amendments of 1976". U.S. Food and Drug Administration.
6. (1994). "Surviving the Dalcon Shield IUD: Women v. The Pharmaceutical Industry". Teachers College Press.
7. Swann, Ph.D., John P. "Regulating Cosmetics, Devices, and Veterinary Medicine After 1938". U.S. Food and Drug Administration.