Breaking News: The FDA Will Not Regulate Your Kid’s Skateboard
The Food and Drug Administration has just issued draft guidance saying that it will not regulate products that help with “general wellness” and “promote a healthy lifestyle,” but pose low risk to peoples’ safety.
The guidance specifies “exercise equipment, audio recordings, video games, software programs and other products” (although I suppose “other products” is not really very specific). The inclusion of exercise equipment is especially alarming. Exercise equipment has been around for generations. The term includes baseball bats, snowboards, and running shoes. Why, in 2015, has it become necessary for the FDA to clarify that it will not regulate these items?
The guidance is a welcome dose of common sense from the FDA, which imposes very burdensome regulations on medical devices. However, it punctuates the need to revisit and rewrite the FDA’s authorizing legislation. The most pressing concern is the risk that the FDA will regulate smartphone apps and related software as medical devices.
Representative Marsha Blackburn (R-TN) introduced the SOFTWARE Act last year, which would exempt clinical software and health software from FDA regulation. The SOFTWARE Act is part of the 21st Century Cures initiative, a worthy effort by the House Energy and Commerce Committee to upgrade the entire apparatus of medical innovation in the United States. A big piece of this effort is to update the legislative language that grants authority to the century-old FDA. If it needs to be updated to clarify that the FDA cannot regulate skateboards or yoga mats, Congress should do that too.
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For more about the Food and Drug Administration, see FDAReview.org.