FDA Commissioner Scott Gottlieb, M.D. recently announced the agency’s Digital Health Innovation Plan (the “Plan”)—a new agency-wide initiative to foster “innovation at the intersection of medicine and digital health technology.” Dr. Gottlieb provided an overview of the components of the Plan, which include: (1) guidance documents implementing the digital health provisions of the 21st Century Cures Act; (2) guidance documents on low-risk digital health products; (3) a third-party certification pilot program; and (4) use of real-world evidence to support the development of digital health products. While the Commissioner previewed the new Plan, he explained that details of each component would be forthcoming. The Plan appears to align with the approach previously advanced by the Center for Devices and Radiological Health (CDRH) regarding digital health.
Components of FDA’s Digital Health Innovation Plan
Dr. Gottlieb announced that the Plan will contain the following:
- Implementation of the Digital Health Provisions of 21st Century Cures: The 21st Century Cures Act added section 520(o) of the Federal Food, Drug, and Cosmetic Act (FDCA), to exempt from the definition of “device” five categories of health and medical software functions: (1) administrative support software; (2) wellness software; (3) electronic health records; (4) certain device or laboratory data transfer software; and (5) certain clinical decision support software. Dr. Gottlieb announced that FDA, led by CDRH, will implement the digital health provisions of the 21st Century Cures Act, and “in the coming months” will “publish guidance to further clarify what falls outside the scope of FDA regulation and to explain how the new statutory provisions affect pre-existing FDA policies.” FDA will provide guidance to “clarify our position on products that contain multiple software functions, where some fall outside the scope of FDA regulation, but others do not.”
- Guidance on Low-Risk Digital Health Devices: FDA will issue new guidance on technologies that, although meet the definition of a medical device, “present low enough risks that FDA does not intend to subject them to certain pre-market regulatory requirements.” Such guidance would presumably complement previously released guidance documents on low-risk digital health products, including guidance documents on General Wellness Products (July 2016), Mobile Medical Apps (Feb. 2015), Medical Device Data Systems (Feb. 2015), and Medical Device Accessories (Jan. 2015).
- Third-Party Certification Pilot Program: FDA is considering a third-party certification program to help assess digital health products. Under the pilot program, third-party certification could mean that “lower risk digital health products” could be marketed without FDA premarket review. “Higher risk products” could be marketed with “streamlined FDA premarket review.” Third-party certification could assess whether a company “consistently and reliably engages in high quality software design and testing (validation) and ongoing maintenance of its software products.” FDA hopes that employing a pre-certification program for software as a medical device (SaMD) “could reduce the time and cost of market entry for digital health technologies.” This pilot program appears to resemble a so-called “pre-check” program that has been discussed previously by CDRH officials.
- Post-Market Collection of Real-World Data to Support New Product Functions: FDA intends to allow developers to leverage real-world data gathered through external data sources to “expedite market entry and subsequent expansion of indications.” Dr. Gottlieb cited the National Evaluation System for health Technology (NEST) as an example of a system that can serve as a source of real-world data. NEST is a “federated virtual system for evidence generation composed of strategic alliances among data sources including registries, electronic health records, payer claims, and other sources.” The Medical Device Innovation Consortium (MDIC), a public-private partnership, operates NEST and includes FDA as a member.
CDER and CBER Regulation of Digital Health Products
Stakeholders will be watching closely to see if FDA’s Plan will include guidance specific to digital health offerings associated with drugs and biologic applications. Although the Commissioner called the initiative “agency-wide,” the blog post mentions CDRH specifically, but it does not discuss the level of involvement of FDA’s Center for Drug Evaluation and Research (CDER) or Center for Biologics Evaluation and Research (CBER). As we have reported previously, CDRH has been active over the last few years issuing guidance documents on digital health. With technical assistance provided by CDRH, Congress addressed certain aspects of device-related digital health issues in the 21st Century Cures Act. That said, as many are aware, pharmaceutical manufacturers, and those collaborating with them on digital initiatives, have been navigating the complex legal and regulatory landscape around digital health product offerings associated with their marketed drugs, including whether and when a drug sponsor must seek approval or clearance before marketing digital technologies; the circumstances under which FDA will consider digital content to be drug “labeling;” the extent to which adverse event reporting requirements will attach to information collected or available to sponsors through digital platforms; and the circumstances under which CDER, CBER, or the Department of Justice will consider digital platforms to be advertising and promotion of the sponsor’s drug(s). It remains to be seen how much FDA’s Digital Health Innovation Plan will address key legal and regulatory questions surrounding digital health offerings associated with drugs and biologics.