Digital Health Companies May Find A Faster Path To Market Under The FDA's Digital Health Plan

Author:Ms Pinar Bailey
Profession:Fenwick & West LLP

It looks like the FDA is moving forward—and swiftly—with the digital health plan articulated in FDA Commissioner Scott Gottlieb's June blog post, previously outlined in this post. Closely tracking the commissioner's post, the Center for Devices & Radiological Health released an action plan about its Digital Health Program and posted a notice for comment for a Software Pre-Certification Pilot Program.

The pilot program is a first step in the FDA's reimagined digital health product oversight approach. What makes it stand out from the FDA's prior regulatory approach is its aim "to develop a new approach toward regulating this technology - by looking first at the software developer or digital health technology developer, not the product."

Under its firm- and developer-based approach, the CDRH could "pre-certify" eligible digital health developers who "demonstrate a culture of quality and organizational excellence based on objective criteria, for example, that they can and do excel in software design, development, and validation (testing). Pre-certified developers could then qualify to be able to market their lower-risk devices without additional FDA review or with a more streamlined premarket review."

In his blog post, the FDA's Scott Gottlieb announced that in August companies can submit a statement of interest that includes the qualities listed above and request participation in the pilot to The FDA's Digital Health Team will evaluate submissions and select companies that reflect the broad range of software developers later in the month. "A critical component is that we will include small and large companies, traditional and non-traditional medtech companies, and products that range in risk," Gottlieb said in his post. (Read more about how the CDRH is recruiting participants to the pilot program.)

The Digital Health Software Precertification (PreCert) Program

Under the new program, digital health companies may find a faster path to bring their products into market and update more efficiently the products already in the market. Indeed, the CDRH's action plan imagines that premarket review under this new oversight regime could include "reduced submission content, faster review of that content by CDRH staff, or both." In addition, the action plan indicates that firms that have "pre-cert" status could "collect real-world data postmarket that might be used to affirm the regulatory status of the product, as well as to...

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