The FDA, Mobile Apps, and Your Medical Practice

Make sure the medical apps you use aren't subject to FDA oversight, or other regulatory requirements.

It is hard to escape the utilization of smartphones or tablets and, in particular, the "apps" that are available. However, it's important to check that the ones you are using don't require regulatory oversight.

In healthcare, the Food and Drug Administration (FDA) has become involved. Two years after the draft guidelines were released, on September 23, 2013, the FDA issued its anticipated final guidance.

The publication Mobile Medical Applications - Guidance for Industry and Food and Drug Administration Staff expressly states that some of the recommendations are “non-binding.” And, importantly, the FDA indicates that many mobile apps are not medical devices (meaning such mobile apps do not meet the definition of a device under section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), and FDA does not regulate them.

Some mobile apps may meet the definition of a medical device but because they pose a lower risk to the public, FDA intends to exercise enforcement discretion over these devices (meaning it will not enforce requirements under the FD&C Act). The majority of mobile apps on the market at this time fit into these two categories.

In essence, some apps are more akin to a bandage then a pedicle screw. The apps that are analogous to the classification and approval process for a Band-Aid compared to that of a pedicle screw are those that pose a lower risk of harm to an individual. But, unlike the device classifications under section 201(h), certain medical apps are not subject to the FD&C Act requirements.

The best place to look for whether an app is subject to the FDA’s regulatory oversight is Appendix C of the Guide, as well as the FDA's "Products and Medical Procedures" website. Still, providers should consider if the app meets other regulatory requirements, such as HIPAA and the Health Information Technology for Economic and Clinical Health Act, or HITECH Act. Failure to do so may still mean penalties.