Agency also launches voluntary pilot program as first step in developing software pre-certification program.

On July 27, the US Food and Drug Administration (FDA or Agency) published its Digital Health Innovation Action Plan, which provides details and timelines for implementation of the 21st Century Cures Act and describes other activities FDA is undertaking to develop an innovative approach for the regulation of digital health products.  

As part of this plan, FDA is announcing a voluntary pilot program intended to help create a new pre-certification program for eligible digital health developers. The objective is to create a new program that would allow FDA to pre-certify developers that meet certain quality and other criteria. Pre-certified developers would then be able to market their lower-risk software devices without FDA premarket review or with a more streamlined review and more limited data requirements.

This new action plan signals FDA’s continued commitment under Commissioner Scott Gottlieb to further optimize digital health regulation and fulfill its obligations under the recently enacted 21st Century Cures Act.

Issuance of Guidance to Implement 21st Century Cures Act Provisions and Clarify FDA’s Oversight of Software

FDA intends to issue three new draft guidances and two final guidances between the end of 2017 and the first quarter of 2018.

The three new draft guidances are the following:

• 21st Century Cures Implementation Guidance. By the end of 2017, the Agency plans to issue a draft guidance to interpret several of the medical software provisions in the 21st Century Cures Act and to explain their impact on FDA’s preexisting policies. As we described in a prior post, the language used in the 21st Century Cures Act does not precisely “track” language used in existing FDA guidances—including the Mobile Medical Applications guidance, the General Wellness guidance, and the Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices guidance. Thus, a new guidance is needed to understand precisely what products are exempt from the statutory definition of “device” pursuant to the new law.

• Clinical Decision Support Software. FDA plans to issue during the first quarter of 2018 the long-awaited guidance on clinical decision support software. Prior governmental announcements by the Office of the National Coordinator for Health Information Technology and FDA already created ambiguity regarding what clinical decision support (or “CDS”) technologies are or will be subject to regulation, and this ambiguity has only been enhanced by language in the 21st Century Cures Act (as noted in our prior post). Accordingly, this new guidance will be of particular importance to many in the digital health industry.

• Multifunctionality. The 21st Century Cures Act raises the issue of how FDA will review products that include both regulated and unregulated functions. Developers of wearable products that include sensors to assess both health/fitness and medical conditions increasingly will face this scenario, and the new draft guidance will provide important clarification on how FDA reviewers will evaluate these multifunctional products. FDA stated that its goal is to issue the draft guidance during the first quarter of 2018 for public comment.

Additionally, FDA has stated that it will finalize the following guidance documents, which were previously issued in draft form:

• Deciding When to Submit a 510(k) for a Software Change to an Existing Device. This document, which issued in draft in August 2016, provides guiding principles for medical device manufacturers on the type of software modifications that may necessitate the submission and clearance of a new 510(k). FDA intends to finalize this guidance before the end of 2017.

• Software as a Medical Device (SaMD): Clinical Evaluation. As described in our prior post, FDA proposed adoption of this International Medical Device Regulators Forum (IMDRF) guidance document in October 2016. FDA expects IMDRF to finalize this document in September 2017, after which FDA will issue a final guidance document “adopting the internationally converged principles, as appropriate.” However, it remains to be seen whether FDA intends to simply adopt the IMDRF version or, as suggested by some of the public comments, issue its own guidance that incorporates IMDRF’s principles but better aligns with FDA’s existing regulatory scheme, device classification system, and terminology.

FDA Pre-Certification Pilot Program for Digital Health Developers

FDA also announced its intent to launch a voluntary pilot program for digital health developers as part of its effort to create an innovative regulatory framework that recognizes the unique, constantly evolving nature of digital health technology. Specifically, FDA hopes to gather information and experience from the pilot program in order to create a pre-certification program under which FDA would focus on the software developer rather than the product. As noted above, once established, the pre-certification program would allow developers that meet certain criteria established by FDA relating to quality and organizational excellence to become pre-certified by the Agency. Pre-certified developers would potentially be able to market their lower-risk devices without a premarket submission or with a submission that requires less data and information and is reviewed more quickly.

Under the pilot program, FDA is seeking to partner with nine digital health developers to gain a better understanding of how these developers operate. FDA would use this information to create the pre-certification program. Although participants would not become pre-certified under the pilot program, they would have a unique opportunity to influence FDA’s establishment of a potentially groundbreaking regulatory framework for digital health.

FDA began accepting requests for participation in the pilot program on August 1, and the program is scheduled to begin on September 1.