EMERGO SUMMARY OF KEY POINTS:

• The US FDA has rolled out its Digital Health Innovation Action Plan to facilitate faster market access for mobile medical app and technology developers.
• A new pilot program, the FDA Pre-Cert for Software, will emphasize digital health developers rather than their devices and technologies.
• The FDA also plans to add personnel to focus on digital health technology premarket reviews.

Medical device regulators at the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) have published further details on their plans to clarify and improve policies regarding mobile medical applications, wearables and other digital health products.

Announcing what they’re calling the Digital Health Innovation Action Plan, CDRH officials have identified three key components of the plan: More guidance addressing the 21^st Century Cures Act’s medical software mandates, a new pilot precertification program (FDA Pre-Cert for Software) for digital health product regulatory oversight, and expanding US regulatory expertise regarding digital health technologies. The new details of the plan follow an announcement earlier in 2017 by FDA Commissioner Scott Gottlieb on how the agency would further revise its approach to the digital health sector.

New medical software guidance

First, under the new plan, CDRH will attempt to clarify how (and whether) the following types of medical software listed in the 21^st Century Cures Act will be regulated in the US:

• Mobile medical apps and data systems
• Medical image storage devices
• Medical image communications devices
• Low-risk general wellness and laboratory workflow technologies

CDRH has set a late 2017 deadline for issuing guidance and soliciting public comment regarding regulatory approaches to the afore-mentioned products.

Second, US regulators are planning to issue draft guidance clarifying their approach to clinical decision support software in early 2018. Specifically, this guidance will address clinical decision support software that, according to the 21^st Century Cures Act, no longer falls under FDA jurisdiction.

Third, CDRH will publish guidance on oversight of medical software with some functions that fall under FDA oversight and some that do not, also in early 2018.

Fourth, the FDA intends to finalize guidance explaining when 510(k) registrants must submit new premarket notification applications for software changes to their medical devices. By late 2017, the agency plans to publish such final guidance to help manufacturers determine whether any software modifications they make require new 510(k) clearance of their devices.

Fifth, the FDA has set a goal of finalizing guidance on clinical evaluation principles for Software as a Medical Device (SaMD) proposed by the International Medical Device Regulators Forum (IMDRF) in 2016.

FDA Pre-Cert for Software pilot

The agency is also planning a “reimagining” of how it regulates digital health technologies via the launch of a pilot program, the FDA Pre-Cert for Software, which will essentially evaluate technology developers more so than their products.

Under the program, CDRH would pre-certify developers that “excel in software design, development and validation (testing).” Such developers would then be able to bring their technologies to market in the US without undergoing extensive premarket review—meaning less required submission content, expedited FDA review or both.

Furthermore, post-market data pre-certified developers collect on their technologies could then be used to reaffirm their products’ or devices’ FDA regulatory status. Utilization of the National Evaluation System for health Technology (NEST) as well as third-party certification pathways are also under consideration for the FDA Pre-Cert for Software pilot.

Beefing up CDRH expertise in digital health

Finally, CDRH reports plans to expand personnel at its Digital Health Program  via user fee funding; additional staff will work with premarket reviewers and compliance officers with the goal of improving predictability, efficiency and related issues for digital health product developers seeking to register with the FDA.

As the new program launches and adds participants, Emergo consultants will examine new guidance from the FDA as well as industry buy-in to assess how viable the new US digital health approach proves.

Related Emergo services and resources for the US medical device market:

• US FDA 510(k) premarket notification support
• Medical device design, process and software validation support
• Whitepaper: Is Your Wearable a Regulated Medical Device?