Commemorating the 40th Anniversary of the 1976 Medical Device Amendments

Suzanne Junod

ABSTRACT

2016 marked the 40th anniversary of the passage of the Medical Device Amendments, which charged the U.S. Food and Drug Administration (FDA) with implementing a unique law that required premarket approval for some kinds of medical devices, and offered alternatives for others. While providing better protection to patients and practitioners from under-tested medical devices, it was also specifically written to preserve and promote innovation in the nascent field of biomedical engineering. At the time the law was enacted, FDA’s Bureau of Medical Devices and Diagnostic Products had a relative handful of employees. Today, the Center for Devices and Radiological Health (CDRH) has around 1700 employees. An inventory of medical devices on the market in the mid-1970s, prior to the passage of the device amendments, drew responses from 1000 firms who reported marketing 8000 devices. Today, there are some 18,716 medical device manufacturers (8,995 are U.S. based) and they market around 175,000 different devices. Moreover, 50% of imported product entries regulated by FDA are regulated in CDRH. The first device trade association, the Medical-Surgical Manufacturer’s Association, was founded in 1903, three years before FDA’s founding statute, the 1906 Pure Food and Drugs Act, was enacted. By 1973, there were still only 150 members, 66% of which were small businesses. Today, most medical device manufacturing companies are still small. 75% have fewer than 10 employees and only 3.7% have more than 100 employees. On this anniversary, it seems appropriate to look back at the history of the medical device amendments and the issues and historical circumstances surrounding its passage.

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Food and Drug Law Journal

Volume 72, Number 1

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