FDA Moves to Put Digital Health Plan into Action


Posted May 2, 2018

With the lines between medical devices and software continuing to blur, the Food and Drug Administration (FDA) is moving its efforts to update the regulation of digital health technologies forward by releasing a working model of its Digital Health Software Precertification (Pre-Cert) Program, as well as draft guidance clarifying how the agency will review devices with multiple functions, which is often accomplished through the use of software.

These actions follow through on promises to develop a new regulatory framework for reviewing software as a medical device (SaMD) and to increase the transparency of the regulatory process that the FDA made in its 2017 Digital Health Innovation Action Plan.

"We know that consumers and healthcare providers are increasingly embracing digital health technologies to inform everyday decisions. Given the benefits from empowering consumers, we believe the FDA must encourage the development of tools that can help people be more informed about their health,” said FDA Commissioner Scott Gottlieb in a statement. “Our approach to regulating these novel, swiftly evolving products must foster innovation and maintain our gold standard for safety and effectiveness.”

Launching the Pre-Cert Program

To that end, the FDA has released a working model of its Pre-Cert program, a voluntary pathway intended to streamline the premarket review of SaMD products by certifying the companies that develop them (similar to the Transportation Security Administration’s PreCheck for airline passengers). The formal launch of the FDA’s program, called Pre-Cert 1.0, is expected take place by the end of 2018 and give trusted developers the leeway to update their SaMD products at a faster pace than hardware-based regulation would typically allow.

“Historically, healthcare has been slow to implement technology tools that have transformed other areas of commerce and daily life. One factor that has been cited, among many, is the regulation that accompanies medical products,” according to the working model. “FDA’s traditional approach for the regulation of hardware-based medical devices is not well-suited for the faster, iterative design, development, and type of validation used for SaMD.”

Under the Pre-Cert program, the FDA would rely on an “accredited third party” to assess SaMD developers on the quality of their “software design, testing, clinical practices, real-world performance monitoring, and other appropriate capabilities to qualify for a more streamlined premarket review while better leveraging postmarket data collection on the device’s safety and effectiveness.”

Developers seeking one of two Pre-Cert status levels would be evaluated for “organizational excellence” based on five principles:

  • Product quality
  • A commitment to patient safety
  • Responsible conduct in clinical evaluation
  • A demonstrated commitment to protecting cybersecurity
  • A culture of proactive surveillance, assessment of user needs, and continuous learning

Applicants would also need to demonstrate a “robust mechanism to collect, monitor, and analyze real-world performance of their organization and the products that they deliver,” according to the model.

The FDA, in turn, would increase its postmarket monitoring through increased use of real-world data from medical device registries and other sources.

“This is an important first step to help us explore and evaluate the program model to inform how we establish the Precertification Program,” the FDA wrote in the working model. “FDA will continue to build and refine this working model by incorporating comments received, as appropriate, and will regularly seek additional public input throughout the development of this program.”

Feedback on the working model can be submitted via www.regulations.gov until May 31.

Clarifying the Regulation of Multiple-Function Devices

The FDA also issued draft guidance it said would “provide transparency and clarity to the digital health community about how the FDA intends to review devices with multiple functions,” when at least one of those functions is not subject to FDA regulation.

“The draft guidance offers additional clarity about where the FDA sees its role in digital health, and importantly, where the agency will not be involved,” according to the agency.

Multiple Function Device Products: Policy and Considerations specifies what manufacturers of these products should include in their premarket submissions to the FDA, with an emphasis on the need to determine if any of the device’s non-FDA-regulated functions could “impact the safety or effectiveness” of the device. Such “other functions” could impact the FDA-regulated parts of a device on a software level—such as providing or sharing data that’s used for critical, medically based calculations—or on a physical level, by sharing components such as a device’s memory, screen, or computer processor.

“The FDA recommends that when possible, the device function under FDA’s premarket review should be separated from other functions of the device, and that the higher the degree of separation, the easier it is for the agency to independently review it for safety and effectiveness,” the FDA wrote in the draft guidance.

The FDA is accepting comments on Multiple Function Device Products: Policy and Considerations until June 27 via www.regulations.gov.