Is Your Smart Phone An FDA-Regulated Medical Device? - FDA Announces Plans To Regulate 'Mobile Medical Applications'

An enormous number of software applications have been developed for use on handheld computers such as smart phones, tablet computers, and personal digital assistants. Some of these applications are marketed as suitable for diagnosing or treating disease, or for controlling other machines that are used for these purposes.

On July 21, 2011, the U.S. Food and Drug Administration issued a "draft guidance" discussing how it intends to regulate "mobile medical apps."1 The FDA views handheld computers loaded with these apps to be medical "devices" subject to extensive FDA regulation. The FDA's draft guidance sets out its current thinking regarding when apps will trigger regulatory oversight, and how the FDA intends to enforce its regulations.

Since the FDA will be exercising its authority over industries that may be unaccustomed to FDA regulation, the affected companies are in danger of inadvertent regulatory violations. The FDA is focusing primarily on companies that write or design software for medical apps. But, depending on the circumstances, companies that manufacture or distribute the hardware also face regulatory risk. All companies in any way involved with handheld computers or their apps would be well advised to consult with regulatory counsel to determine how they may be affected by the FDA's device regulations.

The FDA is actively seeking input into its policies. Companies that want a say in the FDA's enforcement practices should promptly submit comments to the new "draft guidance."

Medical Devices and the FDA

The FDA has long had authority to regulate medical "devices," a term that encompasses instruments, machines, implants, and other articles "intended for use in the diagnosis of disease ... or in the cure, mitigation, treatment, or prevention of disease ...." FD&C Act, § 201(h). Regulated "devices" range from extremely simple items, such as dental floss and stethoscopes,2 to pacemakers3 and highly sophisticated medical equipment.

Manufacturers and others involved in the marketing of medical devices are subject to a raft of regulatory requirements. See generally 21 C.F.R. Chapter 1, Subchapter H. Many devices cannot be marketed without prior permission from the FDA. FD&C Act, § 510(k); 21 C.F.R. § 807.100(a). Novel or potentially dangerous devices may be subject to a rigorous premarket approval process requiring expensive and time-consuming clinical trials. See FD&C Act, § 515; 21 C.F.R. Part 814.

Other regulations mandate...