FDA Issues Guidances on Digital Health ToolsBy
The US Food and Drug Administration (FDA) has released a suite of guidances to continue to encourage innovative approaches to the development of digital health tools and to advance the agency’s approach to overseeing these technologies along with it.
“We believe that an appropriate regulatory framework that takes into account the realities of how technology advances plays a crucial role in the efficient development of digital health technologies,” said FDA Principal Deputy Commissioner Amy Abernethy in a September 26, 2019 statement. “We’ve maintained, since we issued our Digital Health Innovation Action Plan in 2017, that our approach to regulating these novel, swiftly evolving products must foster, not inhibit, innovation.”
As part of this plan, the FDA says it has accomplished several key initiatives, including launching and testing the digital health software precertification pilot program and taking steps to modernize its policies.
The new guidances, as part of the Digital Health Innovation Action Plan, address key provisions of the 21st Century Cures Act, signed into law in 2016 to help accelerate medical product development and new innovations. The first guidance, Clinical Decision Support Software, is a revised draft guidance based on review of public comments received on the previous draft published in 2017. The FDA aims to encourage developers to create, adapt and expand the functionalities of software to support providers in diagnosing and treating diseases while also ensuring the software doesn’t introduce unacceptable risk to the patient.
Also issued was the final guidance, Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act, which addresses other digital health provisions included in the Cures Act. It outlines the FDA’s interpretation of the types of software that are no longer considered medical devices under the amended definition of device.
The digital health technologies described in guide 3060 have been previously discussed in existing medical software guidances, but the FDA is also updating four previously issued FDA final guidances to align with interpretations and policies under the Cures Act: Final Guidance on Policy for Device Software Functions and Mobile Medical Applications; Final Guidance on General Wellness: Policy for Low Risk Devices; Final Guidance on Off-The-Shelf Software Use in Medical Devices; Final Guidance on Medical Device Systems, Medical Image Storage Devices, and Medical Image Communications Devices.
Changes to the previously issued guidances include clarification that many products previously under enforcement discretion no longer are medical devices under the 21st Century Cures Act, and therefore are not subject to the FDA’s regulations and oversight.