For both developers and marketers of digital health products, a thorough evaluation of each product’s functionality and proposed marketing claims is critical to understanding whether the FDA will designate the product an actively regulated medical device. Over the last five years, both legislative and agency efforts have yielded laws and policies limiting the focus of regulatory oversight to only a subset of “higher risk” digital health products.
Today, digital health products fall into one of three regulatory categories:
- Not a medical device: Many digital health products do not meet the statutory definition of a “device,” and accordingly, are not regulated by the FDA. Examples include medical device data systems (MDDS) and software that promotes a healthy lifestyle without reference to a specific disease or condition.
- Enforcement discretion: While the statutory definition of “device” remains broad, the FDA has established a number of policies whereby the agency chooses not to actively enforce FDA requirements. Such “enforcement discretion” policies apply to products that include many “lower risk” mobile apps and software intended to help maintain a healthy lifestyle to reduce the risk or impact of certain diseases or conditions.
- Actively regulated medical devices: Though the FDA continues to explore other potential approaches, it generally applies the traditional framework for regulation of medical devices to all other digital health products, such as radiological computer-assisted diagnostic (CADx) software.
Understanding these categories is essential prior to commercial distribution in the United States, as digital health products marketed without the requisite FDA marketing authorization may be, and have been, the subject of not only administrative action but also removal from distribution.
For example, in August 2019, the FDA posted on its recall database the initiation of a recall involving the “Visibly Online Refractive Vision Test,” a mobile medical app that was part of a vision test offered on a telemedicine platform. The product was marketed for use in measuring vision refraction, with the results transmitted to the patient’s ophthalmologist or optometrist. The lack of a marketing application for the product was cited in the recall notice, which followed a 2017 FDA Warning Letter involving the test with the same citation.