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FDA Releases Guidance Suite to Advance Digital Health Policies


The agency aims to encourage innovation while ensuring the health tech is safe.


The U.S. Food and Drug Administration (FDA) today released a guidance suite to promote the development of digital tools for patients to improve their lifestyles and overall health, as well as experience better outcomes.

FDA’s approach to digital health technologies, as stated in its 2017 Digital Health Innovation Action Plan, is to regulate the novel products to foster —not inhibit — innovation.

The guidances look to address key provisions of the 21st Century Cures Act and offer clarity about the agency’s role in advancing safe and effective digital health tools.

Guidance on Clinical Decision Support Software

The agency announced Clinical Decision Support Software, a revised draft based on a review of public comments from its previous draft. The purpose of the guidance it to describe FDA’s approach to clinical decision support software functions.

In the guidance, the FDA clarifies the types of clinical decision support software functions that are intended to help providers and patients inform their management of serious or critical conditions. This includes functions that:

  • Don’t meet the definition of a device amended by the Cures Act
  • Might meet the definition of a device but, based on the agency’s understanding of the risks of the device, the FDA does not intend to enforce compliance with applicable device requirements (premarket clearance and premarket approval requirements)
  • Meet the definition of a device and on which FDA intends to focus its regulatory oversight

FDA will leverage its Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations for its risk-based approach to clinical decision support software regulation.

“We want to encourage developers to create, adapt and expand the functionalities of their software to support providers in diagnosing and treating diseases, while also ensuring the software doesn’t introduce acceptable risk to the patient,” said Amy Abernethy, M.D., Ph.D., FDA’s principal deputy commissioner.

Guidance on Changes to Existing Medical Software Policies

The agency issued the final guidance Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act, which outlines the FDA’s interpretation of software no longer considered medical devices under the amended definition of the device.

“We’re 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 the FDA’s regulation,” Abernethy said.

These technologies can provide great value to patients and healthcare as a whole and tend to be low risk.

Technologies in the guidance have been discussed in previous medical software guidances, so the agency updated four previous issued final guidances to align with the policies:

  • 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 Data Systems, Medical Image Storage Devices and Medical Image Communications Devices

The documents expand the agency’s efforts to encourage innovation and protect public health, Abernethy said.

“Our aim is to provide more clarity on our risk-based approach to digital health products, and, in particular, to provide more detail on those technologies and applications that would no longer be classified as a medical device subject to FDA regulation according to the Cures Act,” she said. “These documents are critical elements of FDA’s comprehensive approach to digital health.”

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