On September 26, 2019, the FDA issued two revised guidance documents addressing its evolving approach to the regulation of digital health technologies. These guidances primarily describe when digital health solutions will or will not be actively regulated by FDA as a medical device. In parallel, FDA also updated four previously final guidance documents to ensure alignment with the new approaches being adopted by the Agency.

As background, FDA issued draft guidance documents in December 2017 that sought to implement section 520(o)(1) of the Federal Food, Drug, and Cosmetic Act (“FDCA”), which was enacted by Congress in the 21st Century Cures Act of 2016 (the “Cures Act”). Those guidance documents raised a number of issues that we discussed on this previous alert.

After receiving comments from stakeholders, the Agency responded by issuing: (i) a revised draft guidance document for clinical decision support (CDS) software (“Clinical and Patient Decision Support Software” or the “CDS Draft Guidance”) and (ii) a final guidance document for other software functions exempted by the Cures Act (“Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act” or the “Software Policies Guidance”).

Here are key takeaways on FDA’s newly-issued guidance:

  • The Agency now classifies decision support software intended for use by both healthcare professionals (HCP) and patients as “clinical decision support” or “CDS” software. Previously the Agency used the term CDS software only for software intended for healthcare professionals, whereas “patient decision support” or “PDS” software was intended for patients or caregivers. FDA now considers all decision support software to be CDS and distinguishes between: (1) “Non-Device CDS,” which must meet the Cures Act criteria, including an intended use by HCPs and (2) “Device CDS,” which includes all CDS intended for use by patients, as well as HCP-facing CDS that do not meet the Cures Act criteria. But the Agency will exercise enforcement discretion for (in other words, not regulate) certain Device CDS intended for use by both HCPs and patients to inform management of non-serious healthcare situations or conditions.
  • FDA incorporates the International Medical Device Regulators Forum (“IMDRF”) Software as a Medical Device Risk Categorization Framework into the Agency’s approach regulating CDS software. FDA utilizes the IMDRF framework for two purposes:
    • First, FDA utilizes the framework to define when software functions do not meet the Cures Act criteria for Non-Device CDS because they go beyond “supporting or providing recommendations,” stating that software functions that drive clinical management or treat or diagnose are not CDS. This application raises some potential issues given that the IMDRF language does not align fully with the statutory language in the Cures Act.
    • Second, FDA utilizes the framework to define those lower-risk Device CDS that are subject to enforcement discretion, as contrasted to those Device CDS – specifically Device CDS intended to address serious and critical situations or conditions – that remain subject to regulation as a device.
  • The new guidance documents address dynamic digital health solutions, such as those that incorporate artificial intelligence and machine learning, and bioinformatics software. FDA’s initial draft guidance documents did not discuss these technologies.
  • In the final Software Policies Guidance, FDA notes that the regulation of software functions that provide for alarms, alerts and flags should be considered under the CDS Draft Guidance and may not always be subject to enforcement discretion. The CDS Draft Guidance proposes to continue enforcement discretion for certain low-risk notifications, but an “alarm” or an “alert” that a healthcare provider or caregiver relies on to make a treatment decision remains subject to FDA regulatory oversight.
  • FDA clarifies that hardware is not exempt from the definition of a medical device under the Cures Act, i.e., hardware that is intended for Cures Act functions, such as general wellness or to transfer, store, and display device data, are not excluded from the definition of a device. However, many of these products are subject to enforcement discretion under FDA’s other guidances.
  • It remains unclear how the new guidance documents relate to or align with FDA’s other digital health initiatives, including the Agency’s proposed frameworks on prescription drug-use-related software (PDURS) and real-world evidence, the discussion paper for artificial intelligence/machine learning (AI/ML)-based software, or the Software Precertification (Pre-Cert) Pilot Program. The CDS Draft Guidance explicitly says that the document does not address Device CDS that is part of a combination product or the labeling requirements for CDS disseminated by or on behalf of a drug or biologic sponsor.

In conjunction with the two revised Cures Act guidances, FDA also updated the following guidances:

By issuing another draft guidance on CDS software, rather than finalizing the previous draft guidance, FDA signals its desire to receive additional stakeholder input before setting policies around CDS software. This also means that it could be many months, or even years, before we see final FDA guidance around CDS software.

Companies who are marketing, developing, partnering, or investing in digital health solutions will want to review the new guidance documents and consider how any changes to FDA’s approach will affect their product portfolios. Companies should consider submitting comments on the CDS Draft Guidance, as well as the Software Policies Guidance given some of the issues noted above. For the CDS Draft Guidance, the FDA docket is open for comments until December 26, 2019.

Tags: Artificial Intelligence (AI), digital health, FDA, Medical Devices, Mobile Medical Apps
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Photo of Christina Kuhn Christina Kuhn

Christina Kuhn advises medical device, pharmaceutical, and biotech companies on a broad range of FDA regulatory strategy and compliance matters. She has experience with cutting-edge and complex medical technologies, including software and digital health products, oncology products, next-generation sequencing, diagnostics, and combination products.…

Christina Kuhn advises medical device, pharmaceutical, and biotech companies on a broad range of FDA regulatory strategy and compliance matters. She has experience with cutting-edge and complex medical technologies, including software and digital health products, oncology products, next-generation sequencing, diagnostics, and combination products.

Christina frequently helps multinational device manufacturers as well as start-up device companies navigate the premarket regulatory process, advising companies on regulatory classification, clinical development strategy, and agency interactions. She also has significant experience counseling medical device companies on postmarket compliance requirements, including those related to advertising and promotion, quality systems and manufacturing, medical device reporting, registration and listing, and recalls. She advises clients on responding to and resolving enforcement actions, such as FDA inspections and Warning Letters as well as Department of Justice investigations.

Christina advises clients on, and performs regulatory due diligence for, corporate transactions, including acquisitions, public offerings, co-development agreements, and clinical trial agreements.

Christina also regularly assists industry associations and medical device and pharmaceutical companies in commenting on FDA guidance documents and rulemaking as well as drafting and analyzing federal legislation.

Christina is a frequent contributor to Covington’s Digital Health and InsideMedicalDevices blogs.

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Photo of Wade Ackerman Wade Ackerman

Wade Ackerman advises companies and trade associations on complex and novel FDA regulatory issues that require coordinated legal, regulatory, and public policy strategies.

Through more than 19 years of experience in private practice and positions within the FDA and on Capitol Hill, Wade…

Wade Ackerman advises companies and trade associations on complex and novel FDA regulatory issues that require coordinated legal, regulatory, and public policy strategies.

Through more than 19 years of experience in private practice and positions within the FDA and on Capitol Hill, Wade has acquired unique insights into the evolving legal and regulatory landscape facing companies marketing FDA-regulated products. He co-leads Covington’s multidisciplinary Digital Health Initiative, which brings together the firm’s considerable global resources to advise life sciences and health technology clients harnessing the power of information technology and data to create new and cutting-edge innovations to improve health and achieve better outcomes for patients.

Until June 2016, Wade served as Senior FDA Counsel to the U.S. Senate Health Education, Labor & Pensions (HELP) Committee Ranking Member Patty Murray (D-WA) and, prior to that, Chairman Tom Harkin (D-IA). While at the HELP Committee, Wade was involved in all major FDA legislative initiatives, oversight hearings, and other Senate HELP Committee activities concerning the FDA and the Federal Food, Drug, and Cosmetic Act. From January 2015 through June 2016, he helped negotiate many of the FDA-related provisions in the 21st Century Cures Act, which included reforms to FDA’s review and approval of new drugs, devices, combination products, and digital health software. He also worked closely with the FDA and other stakeholders as Congress examined legislative reforms in other key areas, including diagnostics and laboratory developed tests, cosmetics, and over-the-counter drugs.

Before taking his Senate role, Wade served for more than five years as Associate Chief Counsel within the FDA’s Office of Chief Counsel. He was responsible for providing legal advice to the FDA’s Center for Drug Evaluation and Research (CDER) and the Office of Commissioner (OC) on a wide range of issues. While at FDA, he also helped to develop and implement the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012 and the Drug Quality and Security Act (DQSA) of 2013—both significant reforms to FDA’s regulatory authorities.

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Photo of Scott Danzis Scott Danzis

Scott Danzis is a partner in Covington’s Food, Drug, and Device Practice Group and chairs the Firm’s Medical Device Industry Group. Scott is a leading expert on the regulation of medical devices, diagnostics, and digital health. He regularly helps clients navigate their most…

Scott Danzis is a partner in Covington’s Food, Drug, and Device Practice Group and chairs the Firm’s Medical Device Industry Group. Scott is a leading expert on the regulation of medical devices, diagnostics, and digital health. He regularly helps clients navigate their most complex regulatory challenges, including strategies for premarket review, postmarket compliance, and enforcement actions. Scott counsels many of the world’s preeminent medical device companies on a range of matters, including advertising and promotion, recalls, quality system issues, medical device reporting, clinical and non-clinical testing, FDA inspections, and other regulatory matters.

Scott previously served in FDA’s Office of the Chief Counsel where he served as the Special Assistant to the Chief Counsel of FDA. At FDA, Scott was involved in a wide range of legal and regulatory matters, including significant rulemaking, enforcement actions, and legislative initiatives.

Scott speaks regularly at conferences regarding FDA regulation of devices and diagnostics, and since 2010 serves as an Adjunct Professor of Law at the Georgetown University Law Center, where he teaches a course on FDA law.

Scott is a graduate of the University of Virginia School of Law where he was the Editor-in-Chief of the Virginia Law Review and elected to the Order of Coif. He also holds a Master’s Degree from George Washington University and a Bachelor of Science from Cornell University.

From 2006 to 2008, Scott served as the Special Assistant to the Chief Counsel of the U.S. Food and Drug Administration. While at FDA, he was broadly involved in a wide range of legal and regulatory matters related to medical devices and drugs. He also worked on implementing key provisions of the Food and Drug Administration Amendments Act of 2007.

Scott has significant experience in the following areas:

  • FDA regulatory strategies, including strategies for the premarket review (510(k)s, PMAs) of medical devices;
  • Appeals and dispute resolution within FDA;
  • IDEs, INDs, and clinical trial regulation;
  • Advertising, promotion, and scientific exchange, including responding to enforcement actions and investigations;
  • Imports and exports of FDA regulated products;
  • QSR and cGMP requirements, including responding to FDA 483s and enforcement actions;
  • Product recalls;
  • Adverse event and MDR reporting;
  • FDA consent decrees and OIG corporate integrity agreements;
  • Regulatory due diligence;
  • Compliance with antifraud statutes, including the anti-kickback statute and the False Claims Act.

Scott recently developed and edited a book on the regulation of in vitro diagnostic products and laboratory testing, In Vitro Diagnostics: The Complete Regulatory Guide (FDLI, 2010). He currently serves as an Adjunct Professor at the Georgetown University Law Center where he teaches a course on the regulation of drugs, biologics, and medical devices.

Scott clerked for the Honorable Chester J. Straub on the U.S. Court of Appeals for the Second Circuit. He is a graduate of the University of Virginia School of Law where he was the Editor-in-Chief of the Virginia Law Review and elected to the Order of the Coif. He holds a Masters Degree from George Washington University in Health Care Management and Policy, and a Bachelor of Science from Cornell University.

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