Under the final guidance, FDA established a regulatory regime with three categories of medical apps: (1) those that are not medical devices at all; (2) those that, while arguably medical devices, pose a low enough risk that FDA will exercise "enforcement discretion" as to their marketing; and (3) those medical apps that are medical devices and will be subject to full FDA control. For a summary of the final guidance prepared by our mHealth, Telemedicine and Health Information Technology Practice Group, please follow this link.
While the final guidance answered many questions on FDA's plans for medical apps, including that the agency would not regulate mobile platforms such as the Android and iOS, the guidance was far from clear in several key areas. For example, what are the parameters of enforcement discretion for Category 2 medical apps? And what is the future for clinical decision support software. We analyzed these key unresolved questions in our October 2013 Client Alert on the final guidance ( click here).
If you have any questions about this blog entry, please contact either of the authors of the Client Alert, Michael A Swit or Lisa Clark, or the attorney in the firm with whom you are regularly in contact.
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