There has been a lot of discussion lately of the Food and Drug Omnibus Reform Act of 2022 (FDORA), which was enacted on December 29, 2022 as part of the larger Consolidated Appropriations Act for 2023 (you can find our blog post on it here). As important as these kinds of future reforms are to medical product developers, we should also take a moment to review last year’s actions and policy updates on digital health from the Food and Drug Administration (FDA) and to reflect on the transformations that have been taking place at the agency as a result of the rapid pace of innovation in the field. The year 2022 marked the conclusion of the five-year Software Precertification Pilot Program and the release of the final Clinical Decision Support Software guidance, among other things, although FDA’s digital health policies generally remained consistent. In this post, we summarize the agency’s key actions in the digital health space in 2022.

Expanding into Extended Reality

Over the past few years, FDA has started a number of initiatives to explore the use of virtual, mixed, and augmented reality (the agency typically uses the term “extended reality” to cover all types of immersive digital systems) as therapeutic devices for use by patients in clinical environments and at home. The agency granted marketing authorization to two virtual reality devices for patient use, EaseVRx for chronic pain (de novo classification) and Luminopia One for treatment of lazy eye in children, in 2021 and the CureSight system, also for lazy eye in children, in 2022. It is also conducting multiple internal research projects on medical extended reality within the Center for Devices and Radiological Health (CDRH).

In conjunction with its internal research, FDA is engaging health care professionals and the industry to learn about possible benefits, as well as the risks and limitations, of medical extended reality systems to guide future decisions about the therapeutic and clinical uses of such devices. A meeting of FDA’s Patient Engagement Advisory Committee in July 2022 provided an opportunity for the agency to hear from experts and researchers in the field of extended reality and its uses, as well as companies developing medical extended reality devices and patients who have experienced such devices. The materials from the meeting are available here.

FDA also published a list of medical extended reality devices that have received marketing authorization on its website devoted to the Digital Health Center of Excellence (DHCoE), which is part of CDRH.

Application of extended reality technology and the metaverse to medicine is an exciting area of development, and we expect FDA to continue to be active in the space and to develop formal policies and guidance on extended reality devices in the near future.

Precertification Pilot Ends with Uncertain Future

FDA’s Software Precertification Pilot Program, launched in 2017 to explore innovative methods and approaches to regulating software as a medical device (SaMD), officially ended in September 2022 (see our previous posts on the Precertification program here and here). Although FDA was able to glean some key insights from the pilot, including a better understanding of SaMD manufacturer practices throughout the product life cycle, including design, development, and management of SaMD products, the agency ultimately admitted that it had encountered significant challenges in implementing the pilot program. Such challenges included:

• limited statutory authorities, which hindered FDA’s ability to gather consistent and harmonized information on manufacturer practices and SaMD performance;

• focusing only on SaMD for De Novo classification, which limited the number of eligible devices and created issues for testing pilot-specific special controls; and

• the small number of participants (only nine SaMD manufacturer were accepted to the pilot program).

You can read FDA’s final report from the pilot program here.

FDA may use its observations from the pilot program when developing new guidance or other policies pertaining to SaMD, but any new rules or guidances must be consistent with the agency’s current statutory authorities. It is very likely that we have seen the end of any FDA software precertification program, unless or until Congress decides to grant the agency specific authority to implement a new or different regulatory regime for SaMD.

Leadership Changes at the Digital Health Center of Excellence

The past year marked a number of watershed changes at the DHCoE, including the departure of Bakul Patel, longstanding CDRH official in many capacities and the first director of the DHCoE, and the naming of a new acting director, Brendan O’Leary. Subsequently, in January 2023, the agency named Troy Tazbaz, former senior vice president at Oracle, as the new director of DHCoE. It will be interesting to see how Mr. Tazbaz, a newcomer to the agency, will direct the DHCoE in further developing the regulatory framework for digital health devices and in building strategic partnerships with industry stakeholders.

Digital Health Guidances

FDA introduced a number of new and revised guidance documents relating to digital health technologies in 2022. The following is a list with brief descriptions of each such agency guidance:

• Clinical Decision Support Software (final guidance) – After a long wait (the previous draft version was published in September 2019), FDA issued a final guidance covering clinical decision support (CDS) software devices on September 28, 2022. You can find our analysis of this critical guidance in this previous post. In addition, FDA created some helpful resources to determine the regulations that may apply to a company’s CDS software or other types of SaMD: a CDS software flowchart, and a Digital Health Policy Navigator.

• Policy for Device Software Functions and Mobile Medical Applications (revised final guidance) – FDA issued an updated version of this guidance in September 2022 to implement changes consisted with the CDS final guidance.

• Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions (draft guidance) – In recent years, FDA has repeatedly emphasized the importance of addressing cybersecurity in medical devices and has made great efforts in keeping its policies and guidance documents aligned with current cybersecurity recommendations. This guidance describes methods for incorporating cybersecurity into the design and development process for connected medical devices (including SaMD) and for maintaining cybersecurity as part of device quality systems throughout the product lifecycle. Once finalized, this guidance will supersede final guidance Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, issued in October 2014. It is also worth noting that FDORA grants the agency new authorities to require cybersecurity plans as part of premarket submissions for so-called “cyber devices,” which will need to be considered and incorporated into any upcoming final guidance on this topic.    

• Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Notification [510(k)] Submissions (final guidance) & Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data in Premarket Notification (510(k)) Submissions (final guidance) – This pair of final guidances describes FDA’s expectations for information included in premarket notification submissions for CADe devices, and specifically for the design of clinical studies to support marketing authorization of such devices. Many companies have developed, or are interested in developing, software with CADe functionality to detect lesions or abnormalities in radiology images for the purpose of assisting human readers, and with the rapid risk of artificial intelligence/machine learning-based software, some manufacturers may seek to develop CADe software that replaces human readers altogether. These guidances are especially useful for companies developing CADe software and preparing for clinical testing and submission to FDA.

• Electronic Submission Template for Medical Device 510(k) Submissions (final guidance) – Although this guidance does not specifically apply to digital health technologies, it represents an important development for all medical device companies, including digital health device manufacturers. FDA released this guidance in conjunction with the announcement that CDRH will accept electronic submissions of device premarket notifications from all applicants using the electronic submission template and resource (eSTAR) tool. The guidance describes the structure of the template (and helpfully cross-references other guidance documents that relate to each section of the template). FDA has designated October 1, 2023 as the date of full transition to electronic submission for premarket notifications, meaning that FDA will no longer accept eCopies of premarket notification submissions for filing and review as of that date.

As the preceding list highlights, digital health is an active and rapidly advancing field both in the private sector and at FDA. We will continue to monitor and report on notable developments in terms of regulatory policies affecting developers and investors in the broader field.