Your Digital Health Regulation Questions Answered

The U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) regulates medical devices, including software-as-a-medical-device (SaMD). Several years ago, the FDA upgraded its division of digital health into a full-fledged center of excellence (DHCoE), and the DHCoE has since been actively updating its resources to keep medical device developers informed regarding the FDA’s thinking and regulatory efforts on the digital health front. The newest such resource is the Digital Health Frequently Asked Questions (DH FAQ) page, which weaves together a number of disparate resources into a friendly, one-stop shop for digital health developers, including those building artificial intelligence (AI) tools that may qualify as SaMD.

The first helpful resource the DH FAQ page provides is a link to the FDA’s Digital Health Policy Navigator, an interactive tool that walks the user through one of the most crucial FDA-related questions: “Is my digital health product a device?”

The navigator tool can provide three answers to that question:

1. The digital health product is likely not a device. This means the digital health developer’s product is not subject to FDA’s oversight, and hence need not be cleared or approved by the FDA. This might be because the product does not meet the definition of device as set forth under section 201(h) of the Food, Drug, and Cosmetic (FD&C) Act, or because the product is expressly excluded from the device definition by section 520(o) of the FD&C Act.^[1]
2. The FDA likely intends to exercise its enforcement discretion regarding the digital health product. This means the FDA does not intend to enforce the requirements under the FD&C Act, however it is afforded the option of changing course and exerting its oversight of the product, since it technically qualifies as a device.
3. The digital health product is likely the focus of FDA’s regulatory oversight. This means that the digital health developer’s product is a device regulated by FDA, which must be cleared or approved through the applicable pathway (e.g., 510(k), Premarket Approval).

Making this device determination is critical for understanding how the FDA may or may not regulate a digital health developer’s product. The DH FAQ page also highlights the Mobile Health App Interactive Tool, jointly created by the FDA, the Office of the National Coordinator, the Office for Civil Rights, and Federal Trade Commission to help digital health developers understand what digital health-specific regulations may apply in addition to those of the FDA. Paying attention to these other regulatory agencies is becoming increasingly important, for example, as highlighted by FTC’s increased scrutiny regarding consumer-facing digital health products and services and enforcement of its recently revived Health Breach Notification Rule.

The DH FAQ also highlights the resources that the DHCoE has put together, which allow digital health developers to search for digital health devices authorized by the FDA. The agency even maintains lists specific to devices enabled by AI/machine learning (ML) and augmented reality/virtual reality (AR/VR) devices. These resources can be especially helpful in understanding what ground has already been trodden by digital health product developers and the then-current regulatory framework applicable to such devices. The FDA also maintains databases for all non-AI/ML and non-AR/VR authorized digital health products, based on their applicable regulatory pathway (namely, 510(k), De Novo, Pre-Market Approval). The FDA continues to be active in putting forward digital health-focused whitepapers, such as the recently released AI & Medical Products whitepaper, detailing how CDRH is working in conjunction with the drugs, biologics, and combination devices side of the FDA (namely, the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, and the Office of Combination Products respectively). Additionally, we expect to see a number of new digital health drafts and final guidances published this year, as set forth on FDA’s CDRH Proposed Guidances List, including one draft and one final guidance related to AI-enabled digital health devices.

Finally, for questions that are not addressed in the DH FAQ, digital health developers can reach out to the DHCoE through three main pathways. The first and most formal is via a 513(g) request for information. This takes additional time and incurs additional cost, but the resulting response from the FDA will be binding. The second is the Pre-Submission or Q-Submission program, which does not carry fees like the 513(g) request, but the resulting response from FDA will be non-binding. The fastest way to get informal feedback from the DHCoE is to reach out to their inbox (DigitalHealth@fda.hhs.gov), where you can pose your question or schedule an informational meeting.

Footnotes:

[1] - E.g., excluding software functions that are “intended for administrative support of a health care facility, including the processing and maintenance of financial records, claims or billing information, appointment schedules, business analytics, information about patient populations, admissions, practice and inventory management, analysis of historical claims data to predict future utilization or cost-effectiveness, determination of health benefit eligibility, population health management, and laboratory workflow.”