Digital Health Innovation Guidances Out

FDA has released a suite of guidances “to continue to encourage innovative approaches to the development of digital health tools, and to ensure the agency’s approach to overseeing these technologies advances along with it.” Principal deputy commissioner Amy Abernathy said in a statement that FDA believes that an appropriate regulatory framework that takes into account the realities of how technology advances plays a crucial role in the development of digital health technologies.

The first guidance, Clinical Decision Support Software, is a revised draft based on review of public comments to a 2017 draft. It is intended to provide clarity on the scope of the agency’s oversight of clinical decision support (CDS) software intended for healthcare professionals, patients, or caregivers. The new draft says FDA’s regulatory approach to CDS functions includes recent changes to the Federal Food, Drug, and Cosmetic Act made by the 21^st Century Cures Act. The guidance clarifies the types of CDS software functions that (1) do not meet the definition of a device as amended by the Cures Act; (2) may meet the definition of a device but for which, based on current understanding of the device risks, FDA does not intend at this time to enforce compliance with applicable device requirements; and (3) meet the definition of a device and on which FDA intends to focus its regulatory oversight.

Also issued was a final guidance, Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21^st Century Cures Act, which addresses other digital health provisions included in the Cures Act. Specifically, it outlines the agency’s interpretation of the types of software that are no longer considered medical devices under the amended definition of device. FDA says it is making clear that certain digital health technologies, such as mobile apps that are intended only for maintaining or encouraging a healthy lifestyle, generally fall outside the scope of FDA regulation. “Such technologies tend to pose a low risk to patients,” the agency says, “but can provide great value to consumers and the healthcare system.”

Since the technologies described in the second guidance have been previously discussed in existing medical software guidances, FDA also released updated versions of four previously-issued final guidances to align with interpretations and policies under the Cures Act: Policy for Device Software Functions and Mobile Medical Applications, General Wellness: Policy for Low Risk Devices, Off-the-Shelf Software Use in Medical Devices, and Medical Device Data System, Medical Image Storage Devices, and Medical Image Communications Devices. FDA says that changes to these documents include clarification that many products previously under enforcement discretion no longer are medical devices under the 21^st Century Cures Act and therefore not subject to agency regulation and oversight.