The FDA July 27 released its Digital Health Innovation Action Plan, which provides details and timelines for the agency’s “integrated approach to digital health” and its implementation of provisions of the 21st Century Cures Act related to digital health technology.

The plan springs from the FDA’s recognition that the agency needed “a regulatory framework that accommodates the distinctive nature of digital health technology, its clinical practice, the unique user interface, and industry’s compressed commercial cycle of new product introductions.”

The FDA said that it was moving toward “a new pragmatic approach” that would “recognize the unique characteristics of digital health technology and the marketplace for these tools,” allowing the agency to “continue to promote innovation of high-quality, safe and effective digital health devices.”

A “key component” of the new approach, the agency said, was its Software Pre-Certification pilot program, which was intended to help the FDA develop “a tailored approach” to these products “by looking first at the software developer or digital health technology developer, rather than primarily at the product,” as the agency has treated medical products traditionally.

FDA regulators intend to use the pilot program “to explore whether and how precertified companies that have demonstrated a culture of quality, patient safety and organizational excellence could be able to bring certain types of digital health products to market without FDA premarket review or after a more streamlined FDA premarket review,” the agency said.

Limits of Traditional Regulation

The FDA has determined that its “traditional implementation” of premarket requirements for digital health technology devices “may impede or delay patient access to critical evolutions of software technology, particularly those presenting a lower risk to patients.”

“For the American people to see the full potential of digital health technologies,” the agency said, “FDA must lean forward and adapt our processes.”

CDRH Digital Health Program

As part of the agency’s recognition of the need for “a new approach for digital health oversight,” the action plan reported, the Digital Health Program of the Center for Devices and Radiological Health (CDRH) has developed “practical policies and approaches” toward some software products, including:

• for mobile medical apps, focusing the FDA’s regulatory oversight on higher-risk products and choosing not to enforce compliance for lower-risk apps;
• determining not to focus its regulatory oversight on medical device data systems and general wellness devices; and
• setting expectations for device manufacturers with respect to cybersecurity concerns.

‘Next Steps’

The action plan identifies three broad “next steps” for the coming year:

Issuing new guidance implementing the 21st Century Cures Act. The legislation, enacted in December 2016, excluded various kinds of medical software from the FDA’s jurisdiction (21 U.S.C. §360j(o)). By the end of 2017, the FDA plans to issue new draft guidance interpreting the Cures Act’s medical software provisions, including policies on medical image storage and communications devices, low-risk general wellness products and laboratory workflow.

In addition, by the end of the first quarter of 2018, new draft guidance will delineate the clinical support software excluded from the FDA’s jurisdiction under the statute, as well as outline the extent of the agency’s oversight of products with both software functions within the FDA’s jurisdiction and software functions not within that jurisdiction. “Consistent with the 21st Century Cures Act,” the action plan reported, “FDA will assess a non-device software function to the extent that it impacts the software function subject to FDA review, including impacts on safety and effectiveness.”

The FDA also projected that it would soon finalize its August 2016 draft guidance on deciding when to provide a new premarket notification (510(k)) submission for a software change to an existing medical device. “Our goal is to issue this final guidance before the end of 2017," the agency said.

CDRH also intends to issue a final guidance adopting, as appropriate, “internationally converged principles” from the International Medical Device Regulators Forum (IMDRF) on the clinical evaluation of software as a medical device (SaMD). The FDA expects the IMDRF Management Committee to vote in September 2017 to finalize the forum’s draft guidance document on clinically evaluating SaMD, which the FDA issued as draft guidance in October 2016.

Reimagining digital health product oversight. Beginning with the Software Precertification pilot program, the agency “intends to develop a precertification program that could replace the need for a premarket submission for certain products and allow for decreased submission content and/or faster review of the marketing submission for other products.”

This streamlined premarket review “could include reduced submission content, faster review of that content by CDRH staff, or both,” the action plan stated. “In addition, firms that take advantage of their ‘pre-cert’ status could collect real-world data postmarket that might be used, for example, to affirm the regulatory status of the product, as well as to support new and evolving product functions.” Third parties also may have a role in facilitating the FDA’s precertification determinations.

Growing the FDA’s expertise. CDRH plans to hire new staff for the Digital Health Program “as supported by additional user fee funding.” The agency’s goal is “to build a cadre of experts with a deep understanding [of] and experience with software development and its application to medical devices,” the action plan stated. In addition, this fall the center will launch an Entrepreneurs in Residence program to gather “real experience in software development to build and structure the digital health function within CDRH.”