Abstract
Since the emergence of medical devices, legislation has been developed to allow the Federal Drug Administration (FDA) to oversee their development, marketing, and usage. This paper discusses the history of the FDA’s involvement in medical devices, current approval processes, and several case examples. Additionally, it discusses both short- and long-term effects with unexpected consequences to U.S. health care delivery.
Highlights
BackgroundBrief overview of historical legislationThe precursor to the Food and Drug Administration (FDA) first emerged in 1906, when President Theodore Roosevelt signed the Pure Food and Drugs Act, which prohibited interstate commerce of misbranded and adulterated food and drugs
In 1970, President Nixon recruited the director of the National Heart and Lung Institute, Dr Theodore Cooper, to chair the Cooper Committee to evaluate the need for medical device legislation
Many are concerned by this process as it is prone to reporter bias - with an estimated less than 5% complication rate being reported to the FDA [6]
Summary
The precursor to the Food and Drug Administration (FDA) first emerged in 1906, when President Theodore Roosevelt signed the Pure Food and Drugs Act, which prohibited interstate commerce of misbranded and adulterated food and drugs. In 2012, the Food and Drug Administration Safety and Innovation Act allowed collaboration between the United States and foreign governments regulations It further simplified new lowto-moderate risk devices to be classified as Class I or II and bypass the 510(k) process. In 2011, reports of vaginal erosions, infections, bladder injury, increased reoperation rates, and organ perforations were associated with these mesh devices Many manufacturers removed their devices from the market when the FDA required them to submit post-market surveillance data in 2012. The popularity of Cobalt-alloy metal on metal total hip arthroplasty devices - in younger patients - stems from their reported longevity This has led to a regained interested in these devices, and popularization in the 1990s, despite robust clinical data after entering the market via the 510(k) pathway as Class II devices. The emergence of new medical devices lacking profound benefits dominates discussions surrounding current and future legislation to modify the current process
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