On Monday, FDA released a final version of its guidance document, Mobile Medical Applications: Guidance for Industry and Food and Drug Administration Staff. The guidance describes FDA’s approach for regulating certain mobile applications (apps) as medical devices under the Federal Food, Drug, and Cosmetic Act (FDCA).
Although the final guidance retains the basic framework of the draft guidance released in July of 2011, it features several significant changes. In particular, the final guidance appears to narrow the scope of mobile apps that FDA intends to regulate as medical devices, and it expands the categories of apps that will be subject to enforcement discretion. At the same time, however, the final guidance leaves open several questions regarding how FDA intends to regulate apps that serve as accessories to other devices, as well as apps that do not clearly fall into the enforcement discretion categories. In addition, while the final guidance also expressly states that it does not address “the approach for software that performs patient-specific analysis to aid or support clinical decision-making,” it does describe categories of apps that are used in supporting clinical decisions.
For a more in-depth discussion of the guidance, click here for our client alert.