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FDA Releases Draft Guidance on Evaluating the Risk and Credibility of AI Used in Establishing Drug and Device Safety, Effectiveness, and Quality

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This post is part of MoFo’s 2025 Intersection of AI and Life Sciences blog series. In this blog series, we explore how artificial...

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We are Morrison Foerster — a global firm of exceptional credentials. Our clients include some of the largest financial institutions, investment banks, and Fortune 100, technology, and life sciences companies. Our lawyers are committed to achieving innovative and business-minded results for our clients, while preserving the differences that make us stronger.Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations. Prior results do not guarantee a similar outcome.

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This post is part of MoFo’s 2025 Intersection of AI and Life Sciences blog series. In this blog series, we explore how artificial intelligence is revolutionizing research, innovation, and patient care in the life sciences. Stay tuned for expert insights regarding the impact of AI on intellectual property, licensing, contracts, regulatory policy, enforcement, privacy, and venture markets in life sciences.On January 6, 2025, FDA published a <a href="https://www.fda.gov/media/184830/download" target="_blank">draft nonbinding guidance document</a> setting out a framework for drug sponsors, manufacturers, and other interested parties (referred to as “sponsors”) to evaluate the credibility of AI models producing data or information intended to support:<ul><li>FDA regulatory determinations regarding a drug’s safety, effectiveness, or quality (i.e., approval of a New Drug Application), or</li><li>Conformance with FDA’s requirements regarding a drug’s safety, effectiveness, or quality (i.e., post-market surveillance).</li></ul>Read the full <a href="https://lifesciences.mofo.com/topics/fda-releases-draft-guidance-on-evaluating-the-risk-and-credibility-of-ai-used-in-establishing-drug-and-device-safety-effectiveness-and-quality" target="_blank">blog post</a>.

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Ashley E. Quinn is an associate in Morrison Foerster’s San Diego office.Ashley’s practice spans the product lifecycle. She defends clients in class action, multidistrict, and other high-stakes litigation in state and federal court. Her substantive experience includes product liability, consumer fraud, environmental law, public nuisance, and warranty. She represents clients in the consumer product, cosmetic, food, technology, pharmaceutical, and medical device industries.Ashley also advises clients as they navigate a product’s lifecycle from development through a product’s end-of-life. Informed by her litigation experience, Ashley provides pragmatic, creative, and informed advice to clients in the consumer product, cosmetic, food, technology, and pharmaceutical space as they evaluate potential product safety and environmental concerns and navigate compliance in areas where the regulatory landscape is uncertain. She counsels clients on product safety, environmental and other regulatory compliance, product liability risk assessment and mitigation, labeling and warning requirements, and product recalls.Ashley counsels companies on compliant environmental marketing and packaging claims, focusing on avoiding greenwashing and ensuring compliance with California and national environmental regulatory requirements, including California Proposition 65 warnings. She combines a business-focused approach with a thorough understanding of both state and federal product safety and environmental laws to help clients mitigate product risks and achieve their sustainability goals without sacrificing commercial success.Ashley graduated with the highest honors from the University of Oklahoma College of Law, where she was elected to the Order of the Coif. While in law school, Ashley served as an articles editor for the Oklahoma Law Review and earned numerous honors, including the American Jurisprudence Awards in Constitutional Law and Civil Procedure. Ashley was a Comfort Scholar and a Dean’s Leadership Fellow, as well as serving on the law school’s board of governors.

Ashley E. Quinn

Associate

Brigid is a food, drug, and medical device lawyer who counsels life sciences companies on a wide range of U.S. Food & Drug Administration pre- and post-market regulatory issues.As the lead of our FDA + Healthcare Regulatory and Compliance Group, Brigid practices across the spectrum of FDA-regulated products, including medical devices, drugs, biologics, cell and gene therapies, food, cosmetics, dietary supplements, tobacco, laboratory-developed tests, in vitro diagnostics, radiation-emitting electronic products, combination products, and products that may not fit neatly into any of these categories. Accordingly, she counsels established and start-up companies in life sciences, healthcare, and consumer products on a wide range of FDA pre- and post-market regulatory issues. Brigid also frequently advises innovative product developers on threshold FDA jurisdictional questions and develops strategies for approval and marketing, while identifying and mitigating regulatory risks.In her day-to-day practice, Brigid advises on:<ul><li>product development and FDA’s pre-authorization requirements;</li><li>advertising and promotion of FDA-regulated products;</li><li>clinical trials regulation, including strategic advice for sponsors in receipt of a clinical hold;</li><li>responses to warning letters, Form 483s, import alerts, and FDA enforcement actions;</li><li>informal and formal dispute resolution for high-stakes issues;</li><li>compliance with FDA regulatory requirements such as current good manufacturing practice (GMP), quality system regulation (QSR), food safety preventive controls, adverse event reports, product recalls, radiological health issues, risk evaluation and mitigation strategies (REMS), pharmacy compounding and the new track-and-trace regulations for prescription drugs; and</li><li>technical legal questions involving the Food, Drug and Cosmetic Act (FDCA), the Public Health Service Act (PHSA), Federal Advisory Committee Act (FACA), Freedom of Information Act (FOIA), and the Administrative Procedure Act (APA).</li></ul>Brigid also has experience in the development, regulation, and procurement of medical countermeasures (MCMs) against chemical, biological, radiological, and nuclear (CBRN) threats and pandemic infectious diseases, including animal rule approvals and special incentives for the development of MCMs.Complementing her focus on FDA regulatory law, Brigid has a strong litigation background and has served as FDA counsel in product liability cases, civil litigation, international arbitration, and FDA enforcement proceedings. She particularly enjoys providing clients with advice that integrates technical, legal, and political considerations.Brigid maintains an active pro bono practice focused primarily on reproductive health and especially enjoys working with inventors who aim to improve health outcomes for mothers and infants in the peri- and post-natal period. She has represented several clients before the Social Security Administration in appealing denials of applications for disability benefits. She has also worked on several appeals in criminal cases in the District of Columbia.Brigid is a graduate of the University of Tulsa, where she earned her B.S. in biochemistry before attending law school at Stanford Law School. Prior to law school, Brigid worked as an Environmental Policy Analyst in the Office of the Secretary at the U.S. Department of Transportation. She has also worked as a benchtop scientist in a number of laboratories, including FDA’s National Center for Toxicological Research.<h4>Representative Experience</h4><ul><li>Counseled online marketplaces regarding FDA compliance and enforcement for a variety of products.</li><li>Advised development-stage companies on regulatory considerations and FDA engagement strategies related to development and launch of products based on disruptive technologies.</li><li>Advised consumer technology companies with respect to potential FDA regulation under the medical device provisions of the FDCA;</li><li>Served as FDA regulatory counsel to clients evaluating compliance issues under reporting provisions of Corporate Integrity Agreements and related negotiated resolutions of government investigations.</li><li>Helped a large, publicly traded drug company comply with the FDA’s new track-and-trace pedigree requirements for prescription drugs.</li><li>Led regulatory team on numerous initial public offerings (IPO), stock and asset purchase agreements, acquisitions, mergers, and other transactions for life science company.</li><li>Provided strategic advice, conducting regulatory assessments and negotiating key FDA-related terms in connection with due diligence for transactions and post-acquisition integration activities.</li><li>Developed policy positions related to FDA regulation of laboratory-developed tests (LDTs) for multiple clients in this space.</li><li>Represented manufacturers in matters involving regulatory letters, inquiries, advisory comment proceedings, competitor complaints and citizen petitions focused on their products and policy issues affecting their strategic priorities.</li><li>Advised on issues related to promotion of drugs and medical devices, including communication of pharmacoeconomic/healthcare economic information (HCEI), communications by medical science liaisons (MSLs).</li><li>Provided solutions-oriented advice to development-stage companies confronting FDA regulatory issues for the first time, including good clinical practices (GCP), investigator-initiated research (IIR), pre-approval communications and strategies for obtaining FDA approval.</li><li>Collaboratively advised client on FDA, ethical, and product liability issues associated with early termination of a clinical study involving an implanted medical device.</li></ul>

Brigid Bondoc

Partner

Erin Bosman is the global co-chair of Morrison Foerster’s litigation department. Erin is also the founder and co-head of the Artificial Intelligence group and former chair of the Complex Litigation + Advisement practice group. Clients value her business strategy, seeking her comprehensive counsel throughout the product life cycle, especially in high-stakes litigation and product recalls.Erin's clients value her litigation acumen, retaining her as national coordinating and trial counsel in class action cases and multijurisdictional and multidistrict proceedings. She navigates complex business relationships and serves as a defense liaison counsel in cases where multiple defendants have conflicting defenses. A skilled negotiator, Erin has a long track record of securing dismissals and favorable settlements for her clients. When trial is needed, her compelling courtroom skills have delivered successful jury verdicts and appellate victories.Outside the courtroom, Erin maintains a robust advisement practice, drawing on her litigation experience to counsel clients on product development, risk assessments, product labeling, and risk mitigation strategies to help them avoid and defeat product liability claims. When necessary, Erin advises on crisis management and guides clients through product recalls, representing clients before the Consumer Product Safety Commission (CPSC).Erin is a problem-solver through and through. In that role, she advises clients on some of their most difficult product questions, with particular focus on emerging technologies in untested regulatory and litigation landscapes. She is a leader in the fields of wearables and digital health, medical device and pharmaceuticals, and consumer products. Erin counsels clients that have innovative products in the technology and artificial intelligence sector. In addition to her knowledge and experience in the AI space, Erin has also advised clients working with autonomous vehicles, sensors, robotics, and IoT.Erin has received numerous accolades for her legal work, including by the Daily Journal, Chambers USA, and The Legal 500 US, where market commentators praised her as “an exceptional strategist with highly effective negotiation skills” who “has the respect and admiration of her team and her clients.” Erin is a two-time recipient of  “Product Liability Lawyer of the Year” from Euromoney America’s Women in Business Law Awards, honoring high-achieving female lawyers and progressive law firms. In 2025, Erin was again recommended in Mass Tort Litigation/Class Actions – Defendants by Best Lawyers in America. The Legal 500 continues to recognize Erin as a Leading Lawyer in Dispute Resolution: Product Liability, Mass Tort, and Class Action. She was also named as a “Top Healthcare Lawyer” by the Daily Journal, honoring her as a leading California lawyer who specializes in healthcare litigation, transactions, and counseling. Erin was also short listed in the Financial Times’ North American Innovative Lawyers Awards in the Most Innovative Legal Practitioner category for her expertise in solving clients’ problems.Erin is a member of the Product Liability Advisory Council (PLAC), a member of the editorial board for Product Liability Law 360, and a former editor of and frequent contributor to MoFo’s <a target="_blank" href="http://classdismissed.mofo.com/">Class Dismissed</a> blog.<h5>More About Erin</h5>In 1997, Erin was a judicial extern for the Honorable James F. Stiven, U.S. Magistrate Judge, Southern District of California. In 1999, she received her J.D. magna cum laude and Order of the Coif from the University of San Diego School of Law. During law school, she was an editor of the San Diego Law Review.

Erin Bosman

Co-Chair, Litigation Department

Julie Park is the practice group chair of Morrison Foerster’s Complex Litigation + Advisement practice group and managing partner of the San Diego office.Julie protects her clients’ products throughout the product life cycle. Drawing on her deep technical and legal experience, she counsels clients on consumer product safety regulation and pharmaceutical and medical device preemption. She manages complex and multijurisdictional litigation both in state and federal court and also guides clients through product recalls.Clients appreciate Julie’s ability to assess both the practical business implications and legal impact of a matter. They also value the way she recommends solutions that meet their objectives.Julie is committed to providing thought leadership for her clients. She is an editor of, and frequent contributor to, MoFo’s <a href="http://classdismissed.mofo.com/" target="_blank">Class Dismissed</a> blog, where she provides insights on class-action and product–related issues affecting companies in the consumer arena. She has been recognized for her writing as a top author in the JD Supra Readers’ Choice Awards, 2016–2019.Julie is also committed to pro bono service and diversity in the legal profession. While at Harvard Law School, she worked at the Harvard Legal Aid Bureau, a nonprofit law firm that provides free legal services. She has continued her pro bono work at MoFo, which has resulted in her being a regular recipient of the Wiley W. Manuel Award from the California State Bar for pro bono contributions. She co-chairs the firm’s Women’s Strategy Committee and has served on the Associates Steering Committee of Athena San Diego, an organization that promotes professional growth for women executives and rising managers in science and technology.Julie brings an industry perspective to her work with MoFo. Before going to law school, she was a medicinal chemist at Pfizer, where she researched cancer drugs.Beyond her impressive legal work, Julie has a life in the arts. She is a professional-level violinist who performs with chamber music groups in the San Diego area and has played with the Harvard-Radcliffe Orchestra, Cambridge University Chamber Orchestra, and La Jolla Symphony.

Julie Park

Chair of Complex Litigation + Advisement

Elena Klonoski is an associate in Morrison Foerster’s Boston office and a member of the firm’s FDA + Healthcare Regulatory and Compliance practice.Elena works with life sciences and food companies to address their most challenging issues. She works broadly across the spectrum of U.S. Food & Drug Administration (FDA)-regulated products, including pharmaceuticals, medical devices, dietary supplements, and food products. Her healthcare regulatory work includes compliance with federal regulation governing health information technology and state law governing the practice of medicine.In addition to her FDA-focused work, Elena works with the firm’s Investigations + White Collar Defense practice on healthcare-related enforcement matters. Prior to joining Morrison Foerster, Elena was a legal intern and extern at the Harvard Law School Food Law and Policy Clinic (FLPC). She prepared materials for and presented on FLPC’s 2023 Farm Bill recommendations to Congressional staff members. Elena was also a legal intern at a cannabis advisory firm, where she researched and wrote internal memos and drafted client letters on various cannabis business legal questions. Before law school, Elena worked at a nonprofit organization in Massachusetts where she organized large-scale events that promoted local food companies.Elena earned her J.D. from Boston University and her B.A. cum laude from Connecticut College. She is a member of the Alpha Kappa Delta International Honor Society of Sociology and received Honors Study and Distinction in the Major Field.