“FDA Approved” in OTC Advertising

Medical devices may be described as “approved” if they are Class III and have gone through the PMA process, or they may be “cleared” if they are Class II and used the 510(k) process. If they are Class I, there is no particular term to describe their marketability. There is also the DeNovo pathway for new low- to moderate-risk devices that would otherwise have to go through the PMA process. A successful De Novo application results in permission to market and classification as Class I and Class II. It is generally agreed that obtaining approval via a PMA is a more-demanding process than receiving clearance.

For prescription and professional medical devices, most manufacturers are careful to use the correct term and in particular to not use the term “approved” inappropriately. This is addressed in 21CFR 807.97, which states that clearance “does not in any way denote official approval of the device” and that “Any representation that creates an impression of official approval of a device because of complying with the premarket notification regulations is misleading and constitutes misbranding.” A reference to this regulatory language is briefly provided in clearance letters that state, “Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97).”

FDA has advised consumers (or at least those who visit the FDA website) in this regard. For example, there is a 2017 post entitled “Is It Really 'FDA Approved?” that also briefly addresses misuse of the FDA logo. There is also a post with a November 2018 updated date entitled “Consumers (Medical Devices)” that addresses the difference between cleared and approved and provides links to a number of individual device types.

Despite these regulations and resources, some marketers of medical devices sold directly to consumers appear to show less care about what terminology they use, or they are being deliberately misleading. This can be demonstrated by doing a general search for particular devices with “FDA approved.” For example, “FDA approved TENS unit” produces many hits, including a “Top 10 FDA Approved” list, none of which is actually approved. A search at Amazon produces similar results. If you type “FDA approved” in the search box, you get a number of specific suggestions including blood pressure monitor, pulse oximeter, TENS units, and thermometers. Looking at just “FDA approved” reveals a knee brace product and a blackhead remover that both include the FDA logo. A back brace includes the logo with “Approved” under it. None of these products is actually approved. A CPAP mask cleaner being advertised on TV in New York includes the words “FDA approved,” which it is not.

The medical device industry should do its part in not only using proper terminology but also in objecting to the use of incorrect terminology by others.