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Wade Ackerman

Wade Ackerman advises companies and trade associations on complex and novel FDA regulatory issues, with a particular focus on cutting-edge technologies that require coordinated legal, regulatory, and public policy strategies. He works with clients across the life sciences and technology sectors—including those developing artificial intelligence, digital health tools, and other innovative technologies—helping them anticipate and navigate rapidly evolving federal, state and global regulatory frameworks.

With nearly two decades of experience in private practice and senior government roles, Wade brings deep insight into the interplay of innovation, health policy, and FDA regulation. Since 2017, he has co-led Covington’s multidisciplinary Digital Health Initiative, which draws on the firm’s global resources to advise companies harnessing data and technology to transform healthcare delivery and improve patient outcomes.

Until June 2016, Wade served as Senior FDA Counsel to the U.S. Senate Health, Education, Labor & Pensions (HELP) Committee, where he played a central role in major FDA legislative initiatives, oversight hearings, and policy development. He helped negotiate key provisions of the 21st Century Cures Act, shaping reforms to FDA’s review and approval of drugs, devices, and digital health software.

Earlier in his career, Wade served for more than five years as Associate Chief Counsel within FDA’s Office of Chief Counsel, advising the Center for Drug Evaluation and Research (CDER) and the Office of Commissioner (OC) on a wide range of drug regulatory and policy issues. He was also involved in developing and implementing significant reforms, including the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012 and the Drug Quality and Security Act (DQSA) of 2013.

On September 30, 2025, the U.S. Food and Drug Administration (FDA) issued a Request for Public Comment seeking input on “practical approaches to measuring and evaluating the performance of AI-enabled medical devices in the real-world,” including strategies for detecting, assessing, and mitigating performance changes over time (the “Request”). 

The Request

Continue Reading FDA Requests Public Comment on Real-World Evaluation of AI-Enabled Medical Devices

FDA recently announced that it will host a public workshop on August 6, 2024 focused on “Artificial Intelligence (AI) in Drug & Biological Product Development.”  Aimed at bringing drug sponsors and AI experts together, the workshop, hosted in collaboration with the Clinical Trials Transformation Initiative, will feature presentations and a

Continue Reading FDA Announces Workshop on AI Used In Drug & Biological Product Development

On March 15, 2024, FDA’s medical product centers – CBER, CDER, and CDRH – along with the Office of Combination Products (OCP) published a paper outlining their key areas of focus for the development and use of artificial intelligence (AI) across the medical product life cycle.  The paper, entitled “

Continue Reading FDA Medical Product Centers Continue Focus on AI

On September 6, Senator Bill Cassidy (R-LA), the Ranking Member of the U.S. Senate Health, Education, Labor and Pensions (HELP) Committee, issued a white paper about the oversight and legislative role of Congress related to the deployment of artificial intelligence (AI) in areas under the HELP Committee’s jurisdiction, including health

Continue Reading Framework for the Future of AI: Senator Cassidy Issues White Paper, Seeks Public Feedback

Last week, the U.S. Food & Drug Administration (“FDA” or the “Agency”) issued a second discussion paper on the use of artificial intelligence (“AI”) and machine learning (“ML”) with respect to drug and biological products, this time focusing on the use of AI/ML in the drug and biologic development process,
Continue Reading FDA Releases Discussion Paper on AI in the Drug and Biological Product Development Process

On March 15, 2023, the U.S. Food and Drug Administration (FDA or the Agency) issued a draft guidance entitled Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers (2023 Draft Guidance). The 2023 Draft Guidance revises the draft guidance for industry the Agency issued in June

Continue Reading FDA Releases Draft Guidance on Electronic Systems, Records, and Signatures in Clinical Investigations

On March 23, 2023, FDA released a Framework for the use of digital health technologies in drug and biological product development (the “DHT Framework”).  This DHT Framework is on the heels of a Discussion Paper the Agency released earlier this month on the use of artificial intelligence (AI) in drug

Continue Reading FDA Seeks Comments on Agency Actions to Advance Use of AI and Digital Health Technologies in Drug Development

As we kick off 2022, several recent developments from FDA suggest that this year could be pivotal for the Agency’s digital health priorities.  From new FDA offices and artificial intelligence guidance, to FDA’s user fee commitments and must-pass legislation in Congress, this post outlines five key issues to watch in
Continue Reading 5 Digital Health Issues to Watch at FDA in 2022

On July 28, 2020, FDA announced the publication of a final guidance on Multiple Function Device Products: Policy and Considerations that outlines FDA’s evolving approach to the regulation of multiple function device products, including software.

The concept of “multiple function” products was introduced by the 21st Century Cures Act
Continue Reading FDA Issues Final Guidance on Multiple Function Digital Health Software and Other Devices

The following guidance could be relevant to manufacturers of software as a medical device (SaMD).  The recently-enacted Coronavirus Aid, Relief, and Economic Security Act (CARES Act) added new section 506J to the Federal Food, Drug, and Cosmetic Act (FDCA). This section requires manufacturers of certain devices to notify FDA of
Continue Reading Client Alert: FDA Issues Temporary Guidance on New CARES Act Provision Requiring Certain Device Notifications to CDRH