FDA Regulation of Health and Fitness Equipment

Abstract

As new "quasi-medical" devices continue to push the bounds of the FDCA definition of a medical device and with growing popular support for using the FDA to regulate previously off-limit products such as tobacco, the FDA may very well broaden its regulatory scope into the health and fitness industry. By focusing on the specific example of the scuba industry, this paper will examine first, whether the FDA has the authority to regulate athletic equipment as medical devices. Part two will explore the plausible reasons for why the FDA in the past has chosen not to regulate athletic equipment and whether those rationales still make good sense. Part three will discuss whether the scuba industry can serve as an example for other sectors of the health and fitness industry that seek to avoid FDA regulation.