Summary

In recognition that the traditional regulatory approach toward moderate to high risk medical devices is not well-suited for current digital health software products, the US Food and Drug Administration published a Digital Health Innovation Action Plan. The plan requires the issuance of new guidance, the development of a digital health precertification pilot program and the internal expansion of FDA’s digital health capabilities.

In Depth

Late last week, the US Food and Drug Administration (FDA) published its Digital Health Innovation Action Plan (Plan). The agency recognized that the traditional regulatory approach toward moderate and higher risk medical devices is not well suited for the fast-paced, iterative design, development and type of validation used for digital health software products today. Going forward, the agency will explore an innovative approach to regulate these types of products. The approach contains three primary prongs: (1) the issuance of new guidance, (2) the Digital Health Software Precertification (PreCert) Program and (3) an internal expansion of FDA’s digital health capabilities.

New Guidance

FDA plans to issue a number of guidance documents that may impact digital health product development and compliance activities, analyses regarding the regulatory status of products in the United States, and the overall regulatory strategy for those products. The proposed guidance includes: (1) guidance concerning the interpretation of Section 3060 of the 21st Century Cures Act (i.e., certain types of software will not be regulated as medical devices), which codifies aspects of the Food and Drug Safety and Innovation Act (FDASIA) Health IT Report and FDA’s Mobile Medical Applications (MMA) guidance; (2) guidance on Clinical Decision Support (CDS) software; (3) guidance on multifunction software and devices; (4) final guidance on submission of a 510(k) for a software change to an existing device; and (5) final guidance on clinical evaluation of Software as a Medical Device (SaMD) in accordance with the International Medical Device Regulators Forum (IMDRF) quality and efficacy standards. Although tentative dates of publication are referenced, the agency provided very few concrete timelines regarding the expected publication date of these guidance documents. As such, companies may choose to continue product strategies and development under the current regulatory framework and industry standards.

PreCert Pilot Program

The purpose of this program is to develop a new firm-based approach toward regulating digital technology, “by looking first at the software developer or digital health technology developer, not the product.” The PreCert pilot will leverage developer input to create a potentially faster and cheaper pathway by determining and confirming criteria that FDA can use to certify developers that reliably manufacture high-quality, safe and effective digital health devices. In other words, FDA envisions that the Center for Devices and Radiological Health (CDRH) could “pre-certify” eligible digital health developers that demonstrate “a culture of quality and organizational excellence” based on the objective criteria identified in the PreCert pilot. Then, pre-certified developers could, in theory, qualify to market their lower-risk devices without additional FDA review or with a more streamlined premarket review. Neither approach is articulated with detail in the Plan or Federal Register. However, referencing similar pilot programs, such as FDA’s accredited third-party inspection program for medical devices, may provide a foundation and operational principles that will similarly guide the digital health PreCert pilot.

Program Details, In Summary

• • The PreCert pilot is a program in which eligible software developers will have the opportunity to shape FDA’s approach to creating an expedited path to market for digital health products.

  • FDA will begin accepting applications on August 1, 2017, and the program will begin on September 1, 2017.

  • FDA is selecting nine firms that satisfy the following-criteria: (1) the company must be developing or planning to develop a software product that meets the definition of a device in section 201(h) of the Federal Food, Drug, and Cosmetic Act (21 USC 321(h)); and (2) the company has an existing track record in developing, testing and maintaining software products demonstrating a culture of quality and organizational excellence measured and tracked by Key Performance Indicators (KPIs) or other similar measures. While participating in the pilot, the company must agree to: (a) provide access to measures described in selection quality number 2, listed previously (KPIs or similar measures); (b) collect real-world, post-market performance data and provide it to FDA; (c) be available for real-time consultations with FDA; (d) be available for site visits from FDA officials; and (e) provide information about the firm’s quality management system.

  • To be considered for the PreCert pilot, companies should submit a statement of interest. More information about the pilot can be found in the Federal Register Notice. 

While participation in the program is a great opportunity to shape policy and form relationships with key stakeholders at FDA, potential participants should consider whether their quality systems and product development processes are sufficiently developed to facilitate meaningful engagement with FDA. Participation may require a commitment of time and resources from the company, but the payoff may be greater insight into FDA’s thinking and approach to the development and regulation of current and future digital health products. Finally, it’s important to remember that although the PreCert pilot offers the potential for an expedited path to market through pre-certification or “streamlined premarket review” (e.g., submission of reduced content and/or expedited review by FDA), clearance or approval of the product are not guaranteed.

In descriptions of the future regulatory pathway, FDA also emphasized the importance of real-world data and mentioned the future possibility of third-party certification of digital health developers. A webinar to discuss and answer questions about the pilot program will be held today (August 1, 2017).

Expansion of Digital Health at FDA

FDA plans to hire new staff for its Digital Health Program. The positions will be supported by user fee funding. The “new staff will work with reviewers, compliance officers, and others within the FDA to improve the quality, predictability, consistency, timeliness, and efficiency of decision making on individual products and firms.” The agency is also launching an “Entrepreneurs in Residence” program in the fall. 

Future Public Meeting and Comments

Stakeholders are invited to comment on the policies, pathways and regulatory tools the agency should consider in designing a new paradigm for overseeing digital health medical devices through the public docket. FDA will hold a public workshop in January 2018 to discuss the Plan and report on and review the PreCert pilot program.