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ARTICLE |

The Medical Profession and the Medical Device Law

MARC S. KARLAN, MD; MUTAZ B. HABAL, MD; DONALD LEAKE, DMD, MD
Arch Surg. 1978;113(12):1400. doi:10.1001/archsurg.1978.01370240022002.
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ABSTRACT

The Medical Device Amendment of May 28, 1976, to the Food and Drug Act empowers the Food and Drug Administration to regulate and set standards for all medical devices from tongue blades to dialysis units. The FDA has set up "advisory panels" with consumer, industry, and professional representation to offer it advice as to whether particular devices require standards, premarket clearance, or quality control. The involvement of nongovernmental agencies in the writing of standards is hoped for but not assured. It is unlikely that cost will be a factor in assessing safety and efficacy. There is ample opportunity during the administration of the law to "lobby" the FDA either directly, through the advisory panel hearings, or in public hearings.

Everyone interested in medical devices is concerned about their safety and efficacy. Standards themselves, however, must also be relevant, safe, efficacious, and cost-effective. Standards may be written and the law administered

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