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 support new and evolving product functions.”

Firms may also take advantage of the National Evaluation System for health Technology to “generate evidence across the total product lifecycle of medical devices by strategically and systematically leveraging real-world evidence, and applying advanced analytics to data tailored to the unique data needs and innovation cycles of medical devices.”

Additionally, the FDA is still considering the role of third-party certification in facilitating its determinations about pre-certification.

On August 1, 2017, CDRH held a webinar to outline the details of the pilot program. The pilot will be limited to nine manufacturers developing or planning to develop software as a medical device (SaMD), i.e. software that is “intended to be used for one or more medical purposes that perform these purposes without being part of a hardware or medical device.” The FDA will use the pilot program to develop criteria using the IMDRF SaMD risk framework and the certification levels of the pilot program. The FDA plans to hold a public workshop in January 2018 to report on its initial findings. 

Regulatory Changes Based on the 21st Century Cures Act

Additionally, the FDA is aiming to issue a new draft guidance for public comment by the end of 2017 with draft interpretations of several of the medical software provisions in the 21st Century Cures Act including policy on:

  • Mobile medical applications
  • Medical device data systems, used for the electronic transfer, storage, display, or conversion of medical device data
  • Medical image storage devices, used to store or retrieve medical images electronically
  • Medical image communications devices, used to transfer medical image data electronically between medical devices
  • Low-risk general wellness products and
  • Laboratory workflow

The 21st Century Cures Act amends Section 520 of the Federal Food, Drug, and Cosmetic Act by excluding from the definition of “device” certain software functions intended for administrative support; for maintaining or encouraging a healthy lifestyle; to serve as electronic patient records; for transferring, storing, converting formats, or displaying clinical laboratory test or other device data and results and certain other related information; and to provide recommendations to health care professionals for clinical decisions, where the user can independently review the basis of the recommendation. Accordingly, the FDA will withdraw regulations for products that are no longer devices based on the effect of the 21st Century Cures Act on existing digital health policies. The CDRH’s action plan further indicates that clinical decision support software will no longer be under the FDA’s jurisdiction.

A Lighter Touch Regulatory Environment in the Making?
With its digital health plan, the FDA is signaling an interest in enabling a patient centered public health that fosters trust in innovative technologies. Programs like the pre-cert pilot are aimed to take into account the importance of timely software iterations and are expected to offer developers a faster way to bring innovative digital health products to the market. While the devil is always in the (implementation) details, the announced changes signal a lowered regulatory burden on digital health developers.