Keeping pace with the ever-changing life sciences industry, Morrison Foerster stays on top of the trends and political, legal, and economic drivers to support striking the balance between innovative discovery and purposeful business planning to assure our clients continued success. MoFo Life Sciences shares timely legal and business insights and in-depth analyses on trends and the complex technologies at the heart of the global pharmaceutical, biotechnology, diagnostics, medical devices, digital health, and AgTech fields.Learn more about our <a href="https://www.mofo.com/capabilities/life-sciences-healthcare" target="_self">Life Sciences practice</a>.<h2 dir="ltr">ABOUT MORRISON FOERSTER</h2>Morrison Foerster is a leading global law firm that transforms complexity into advantage for its clients. Our clients include some of the largest financial institutions, banks, consulting and accounting firms, and Fortune 100, technology, and life sciences companies. Highlighting the firm’s commitment to client service, leadership in market-changing deals and impact litigation, and values-based culture, Morrison Foerster has been repeatedly recognized as one of the top 10 firms on The American Lawyer’s A-List. Year after year, the firm receives significant recognition from Chambers and The Legal 500 across their various guides, including Global, USA, Asia‑Pacific, Europe, UK, Latin America, and FinTech Legal. Our lawyers passionately care about delivering legal excellence while living our values. Morrison Foerster has a long-standing commitment to creating a culture that respects and celebrates differences, while providing an inclusive environment. The firm has achieved Mansfield Certification Plus since 2018 as a result of successfully reaching at least 30 percent women, communities of color, and LGBTQ+ lawyer representation in a notable number of current leadership roles and committees. The firm also has a long history of commitment to the community and society through providing pro bono legal services, including litigating for civil rights and civil liberties, improving public education and fostering the wellbeing of children, advocating for veterans, promoting international human rights, enforcing the right to asylum, and safeguarding the environment.

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Dr. Meghan Poon counsels clients on patent preparation and prosecution, portfolio strategy, and IP due diligence in the areas of biotechnology and biologics. She has significant experience in diverse technologies including antibodies, cell therapies, gene therapies, diagnostics, and gene-edited plants. She represents clients ranging from large international pharmaceutical companies to midsized companies, startups, and universities.Meghan has filed numerous Patent Term Extension applications to secure additional term for her clients’ patents, which cover FDA-approved products. In addition, Meghan has extensive experience addressing complex obviousness-double patenting and subject matter eligibility issues impacting her clients’ patent portfolios. Meghan also represents clients in both investor-side and target-side due diligence, in deals from seed funding to initial public offerings.Prior to law school, Meghan attended graduate school at the University of California, Los Angeles, where she received a Ph.D. in biological chemistry based on her work on protein-protein and protein-DNA interactions at a molecular level. Meghan is the author of several scientific publications and has presented her research at international conferences.Meghan received her J.D. from the University of Southern California Law School and spent a year as a visiting student at Santa Clara University, where she focused on intellectual property.

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Dr. Meghan Poon counsels clients on patent preparation and prosecution, portfolio strategy, and IP due diligence in the areas of biotechnology and biologics. She has significant experience in diverse technologies including antibodies, cell therapies, gene therapies, diagnostics, and gene-edited plants.

Meghan Poon

Wolfgang advises clients on contentious and non-contentious matters involving their most valuable intellectual property assets in life sciences, digital, and high-tech industries.His subjects of focus include research and development collaborations, complex licensing agreements, and other technology transactions, as well as know-how protection strategies, and employee invention law. He also has substantial experience in litigating patents, trademarks, and other intellectual property assets, often in a multijurisdictional context. In addition, Wolfgang and his team frequently clear trademarks and ad campaigns and prosecute trademark applications.Wolfgang is co-editor of our <a href="https://lifesciences.mofo.com/" dir="ltr" target="_blank">MoFo Life Sciences Blog</a>.Wolfgang is a partner of Morrison Foerster based in our German office in Berlin.<h4 dir="ltr">Representative Transactional Matters</h4><ul dir="ltr"><li>U.S.-based BioTech fund on various research collaborations and other transactions with German start-ups or research institutions.</li><li>Negotiate multimillion-euro strategic partnership between two AgTech leaders concerning the development and commercialization of pest-resistant transgenic traits.</li><li>Craft global multi-million collaboration regarding AI-powered robotic MaaS.</li><li>UK-based digital health company on product roll-out of RPM applications in Germany; coordinate international expansion.</li><li>Advise numerous German start-ups on their U.S. expansion.</li><li>Draft diverse global patent and know-how license agreements in the areas of AgTech and life sciences—including gene licensing and licensing of genome editing technologies (e.g., CRISPR)—and medical devices; draft correlating supply and distribution agreements.</li><li>Structure IP rights in connection with joint ventures and other M&A transactions, including the carve-out of a patent-heavy semiconductor business comprising nine jurisdictions into a German–U.S. joint venture.</li><li dir="ltr">Advise on government-funded, multi-partner R&D projects and/or R&D projects with academic institutions, as well as on employee invention law.</li></ul><h4 dir="ltr">Representative Contentious IP Matters</h4><ul dir="ltr"><li>Lead counsel in an international dispute between software companies on rights and obligations following termination of a multi-million licensing and distribution arrangement; coordinate local counsel.</li><li>Defend Japanese chip manufacturer in high-profile SEP-litigation; advise on global settlement arrangement.</li><li>Represent leading internet retailer in patent infringement and concurrent invalidity proceedings in the context of a multijurisdictional dispute concerning touch-screen technology.</li><li>Represent diverse pharmaceutical and life sciences companies in national and cross-border patent infringement proceedings and other technology-related disputes, including preliminary injunctions as well as pre‑trial discovery and inspection proceedings, concerning, inter alia, drug-coating technologies, toner cartridges, medicinal gases, transgenic plants, and vaccines.</li><li dir="ltr">Conduct trademark, copyright, and false advertising litigation, including, most notably, a high-profile trademark litigation for a German bank, and a nine-country cross-border trademark litigation involving a famous pharmaceutical brand.</li></ul>

Dr. Wolfgang Schönig berät Mandanten zum Schutz des geistigen Eigentums sowohl in streitigen als auch nichtstreitigen Angelegenheiten, mit einem besonderen Fokus auf die IP-rechtliche Beratung von Unternehmen aus den Bereichen Life Sciences, Digitalwirtschaft und High-Tech.Zu seinen Beratungsschwerpunkten gehören Forschungs- und Entwicklungskooperationen, komplexe Lizenzvertragsgestaltungen und andereTechnologie-Transaktionen, sowie Know-how-Schutz-Strategien und das Arbeitnehmererfinderrecht. Er verfügt zudem über umfangreiche Prozesserfahrung zur Durchsetzung von Patenten, Marken- und anderen IP-Rechten, häufig auch in einem grenzüberschreitenden Kontext. Darüber hinaus bewertet Dr. Wolfgang Schönig zusammen mit seinem Team regelmäßig die Rechtskonformität von Werbekampagnen, prüft die Verfügbarkeit von Marken und entwickelt entsprechende Anmeldestrategien.Dr. Wolfgang Schönig ist Co-Editor des Life Sciences Blogs von Morrison Foerster.Er hat seinen Doktortitel an der Heinrich-Heine-Universität Düsseldorf und seinen LL.M. an der Fordham School of Law in New York erworben, jeweils mit Schwerpunkt im gewerblichen Rechtsschutz. Seinen MBA-Abschluss erhielt er von der European University in Barcelona.Dr. Wolfgang Schönig ist Partner des deutschen Büros von Morrison Foerster in Berlin.<h4 dir="ltr">Repräsentative Transaktionen</h4><ul><li dir="ltr">BioTech-Fonds mit Sitz in den USA bei verschiedenen Forschungskooperationen und anderen Transaktionen mit deutschen Start-ups oder Forschungseinrichtungen</li><li dir="ltr">Verhandlung einer hochvolumigen strategischen Partnerschaft zwischen zwei Technologieführern im Bereich Crop Science betreffend der Entwicklung und Kommerzialisierung von bestimmten Resistenzen</li><li dir="ltr">Gestaltung einer globalen Multi-Millionen-Zusammenarbeit für KI-gestützte Roboter</li><li dir="ltr">Ein in Großbritannien ansässiges Unternehmen für digitale Gesundheit bei der Markteinführung von RPM-Anwendungen in Deutschland; Koordination der internationalen Expansion</li><li dir="ltr">Beratung zahlreicher deutscher Start-ups bei deren US-Expansion</li><li dir="ltr">Strukturierung und Verhandlung diverser Patent- und Know-How-Lizenzen in den Bereichen Ag Tech und Life Sciences – einschließlich Fragen zu genome editing wie CRISPR-Medizingeräte, sowie Gestaltung von Softwarelizenzverträgen und Erstellung korrespondierender Liefer- und Vertriebsvereinbarungen</li><li dir="ltr">Strukturierung von IP-Rechten im Zusammenhang mit Joint Ventures und anderen M&A-Transaktionen, darunter die Koordination eines neun Länder umfassenden IP Carve-Outs im Rahmen eines Halbleiter-JVs</li><li dir="ltr">Beratung zu staatlich geförderten Multi-Partner F&E-Projekten und/oder F&E-Projekten mit akademischen Einrichtungen sowie zum Arbeitnehmererfindungsrecht</li></ul><h4 dir="ltr">Repräsentative IP-Streitigkeiten</h4><ul><li dir="ltr">Lead Counsel in einem internationalen Rechtsstreit zwischen Softwareunternehmen über Rechte und Pflichten nach Beendigung einer millionenschweren Lizenz- und Vertriebsvereinbarung; Koordinierung der lokalen Anwälte</li><li dir="ltr">Verteidigung eines japanischen Chipherstellers in einem prominenten Streitfall bezüglich Standardessentieller Patente (SEP); Beratung zu einer globalen Vergleichsregelung</li><li dir="ltr">Verteidigung einer führenden Internetplattform gegen Ansprüche eines Patenttrolls wegen vermeintlicher Verletzung von Patent bezüglich Touchscreen-Technologie sowie korrespondierende US-Streitigkeiten</li><li dir="ltr">Vertretung von Pharma- und Life Science-Unternehmen in nationalen und grenzüberschreitenden Patentverletzungsverfahren und anderen technologiebezogenen Streitigkeiten, einschließlich einstweiliger Verfügungsverfahren und vorprozessualer Beweissicherungs- und Besichtigungsverfahren, unter anderem in Bezug auf Arzneimittelbeschichtungstechnologien, Tonerkartuschen, medizinische Gase, transgene Pflanzen und Impfstoffe</li></ul>

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Wolfgang Schönig is a partner of Morrison Foerster (International) LLP based in our German office in Berlin. His practice specialty is advising on IP aspects relative to transactions in, among others, the life sciences, AgTech and pharmaceuticals industry, as well as legal representation in IP disputes. Wolfgang is specialized in research and development collaborations, complex licensing agreements, technology acquisitions, know-how protection strategies, and employee invention law.

Wolfgang Schönig focuses his practice on IP aspects relative to transactions in the digital, telecoms, high tech, life sciences, and pharmaceuticals industry, as well as legal representation in IP disputes.

Wolfgang Schönig advises clients on IP aspects relating to transactions in, among others, the life sciences, AgTech and pharmaceuticals industry, as well as legal representation in IP disputes. His additional focus areas include research and development collaborations, complex licensing agreements, technology acquisitions, know-how protection strategies, and employee invention law.

Wolfgang Schönig

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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.A core strategic question facing life sciences companies developing novel AI-implemented methods is whether to file for patent protection or to keep the methods as trade secret.One successful approach is to develop a hybrid strategy for patents and trade secrets based on current and future company goals, following the considerations outlined below.The Basics: Patents and Trade SecretsPatents protect new, useful, and non-obvious inventions. Life sciences companies can pursue patents to cover, for example, AI-based algorithms, AI-based devices, or drugs developed by AI. In the United States, patent applications become publicly available 18 months after filing and granted patent protection lasts 20 years from the earliest non-provisional filing date. To obtain patent protection globally, companies need to file and prosecute patents at various patent offices, which increases the costs associated with obtaining patent protection.Trade secrets protect confidential information that derives value by virtue of not being publicly known. Life sciences companies may choose to keep software code and other specific aspects of AI-based methods confidential. Unlike patents, protections associated with trade secrets are indefinite as long as reasonable efforts are made to maintain secrecy. Life sciences companies may take reasonable efforts to protect trade secrets by implementing internal trade secret policies.Considerations:Deciding whether to file a patent application or maintain a trade secret for AI-enabled life sciences inventions involves weighing business and legal considerations.AvailabilityAs an initial matter, the requirement to maintain trade secrets as confidential means that trade secret protection is simply not available for some life sciences applications of AI. Technologies that are inherently exposed to the public cannot be kept as a trade secret. For example, a graphical user interface cannot be kept as trade secret, but may be patentable. On the other hand, assays used to select a lead compound from an AI-generated list and methods of manufacturing the compound identified by AI may be kept as trade secrets or, alternatively, may be patented.EnforceabilityTrade secret protection cannot protect against independent development by another entity or reverse-engineering. Even when trade secret protection does apply, trade secret protection can be hard to enforce because a trade secret owner must show that a third party improperly acquired or improperly disclosed the information despite the owner’s reasonable efforts to maintain secrecy. Thus, the chain of information transfer from the holder of the trade secret rights to a third party is a key element for a potential enforcement suit. In comparison, enforcing a patent requires the patent holder to show a competitor is merely practicing the invention covered by at least one claim of the patent holder’s valid patent. Under patent law, how the potential infringer acquired knowledge of the invention is irrelevant. At the intersection of life sciences and AI, the risk of independent development or reverse-engineering may be high if multiple companies are relying on publicly available data to train models.Freedom to OperateEven if a company does not plan to offensively use patents by suing infringers, patents create prior art for third parties and can thus prevent third parties from patenting their own IP on the technology. Thus, filing for patent applications may create public disclosures that ensure later developments by third parties cannot as easily prevent an earlier party from continuing to practice and innovate in the space. On the other hand, if patents are not filed by the earlier innovator, and all IP is kept as trade secret, then a third party who independently develops the same technology and files for patent protection may be able to prevent the first company from practicing the invention or from continuing to effectively innovate in the space.Business Model and Demonstrating InnovationThe company’s business model plays a role in patent protection and trade secret protection decisions. Some AI-enabled life sciences companies innovate and generate revenue through partnerships and/or licensing of AI discovery platforms. The key innovative functionalities of the platform may be disclosed to partners or licensors, making them ineligible for trade secret protection.Other AI-enabled life sciences companies develop and use AI platforms for drug discovery but ultimately plan to manufacture and sell the drugs themselves. For these companies, patent filings can be an important mechanism for demonstrating innovation to investors. Demonstrating innovation through patent protection for a platform may be particularly important at early stages of a company when product development may take additional time.Takeaways:Life sciences companies using AI often have evolving business models. For example, the company may begin with platform technology for discovery and then evolve into products that can be licensed, manufactured, and sold. We recognize that the balance between both IP types may shift as the business strategy changes and hybrid approaches should be considered.One strategy is to file for patents to cover high-level algorithms and the practical applications of their AI methods, while relying on trade secret protection for low-level implementation details, model finetuning, and optimization before products are developed and sold. These early patents can be used for licensing the platform or to demonstrate innovation to investors. At later stages of development, it may be advisable to apply for patents covering revenue-generating products and to keep new developments to the platform, although patent-eligible, as trade secret. By developing patent practitioner teams with experience in life sciences and in technology, we are able to set life sciences companies up for success early and work with them as they grow.

Patents and Trade Secrets in AI and Life Sciences

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Briana’s practice focuses on patent preparation, prosecution, and counseling in the areas of biotechnology, pharmaceuticals, and artificial intelligence.

Briana Erin Mittleman Ph.D.

Briana Mittleman

Dr. Meghan Poon counsels clients on patent preparation and prosecution, portfolio strategy, and IP due diligence in the areas of biotechnology and biologics. She has significant experience in diverse technologies including antibodies, cell therapies, gene therapies, diagnostics, and gene-edited plants. 

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Josh Crawford's practice focuses on domestic patent prosecution, international patent portfolio management, patent infringement and validity determinations, inter partes review proceedings, and IP lit

Joshua A. Crawford

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Patents and Trade Secrets in AI and Life Sciences

Recent Digital Health-Related FDA Announcements

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A core strategic question facing life sciences companies developing novel AI-implemented methods is whether to file for patent protection or to keep the methods as trade secret.

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 released a draft guidance entitled <a href="https://www.fda.gov/media/184856/download" target="_blank">Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations</a>. In accordance with FDA’s total product life cycle (TPLC) approach to the oversight of medical devices, the draft guidance outlines marketing submission content recommendations for devices that include at least one artificial intelligence (AI)-enabled device software function, as well as recommendations for the design, development, deployment, and maintenance of such devices. The guidance also provides a recommended approach to transparency and bias for these devices, which FDA encourages developers to incorporate from device design through decommission.The guidance encourages early engagement with FDA, especially when the device involves new and emerging technology or when device validation involves novel methods.Comments and suggestions regarding the draft guidance must be submitted by April 7, 2025. If you would like assistance in making a comment or suggestion, please reach out to the FDA + Healthcare Regulatory and Compliance team at Morrison Foerster.Information That Sponsors Should Include in a Submission for an AI-Enabled Device[1]Device DescriptionThe device description should provide information that helps FDA understand the characteristics of the AI-enabled devices, such as device inputs and device outputs, how AI is used to achieve the device’s intended use, the level and type of training that intended users have and/or will receive, and any calibration and/or configuration procedures that must be regularly performed by users. Additionally, sponsors should include a description of all configurable elements (i.e., alert thresholds), as well as whether the users who make configuration decisions require any qualifications or training.User Interface InformationSponsors should include information about the user interface and device workflow, including how information is presented to users. This can be conveyed through different methods, such as photographs, a written description, example reports, and recorded video.Labeling InformationAn AI-enabled device’s labeling should explain many pieces of information to the user at an appropriate reading level, such as how AI is used to achieve a device’s intended use, what the model output means, the degree of automation that the device exhibits, and installation and implementation instructions. The labeling should also describe the model architecture, model development data (including demographic distributions), performance data (including primary endpoints of the validation study), device performance metrics across important subgroups, performance monitoring, and known limitations.Risk Management FileSponsors should provide, as part of a “Risk Management File,” a risk management plan, including a risk assessment.Training and Testing Data InformationSponsors should include in a marketing submission information on data collection, development and test data independence, reference standards, and representativeness. The draft provides a template for organizing this information that lists specific descriptions and information that should be provided. If there are any differences in the data management between the development phase and the validation phase, the sponsor should explain the differences and justify them.Model Description and DevelopmentSponsors should include descriptions of each model used as part of AI-enabled devices, including any quality control criteria. Additionally, sponsors should include a description of how models were trained and an explanation of any pre-trained models that were used.Validation TestingSponsors should include validation testing that provides objective information to characterize the model’s performance. The draft discusses both performance validation and human factors validation (or, alternatively, an evaluation of usability; see Appendix D). Sponsors should include information regarding all study protocols, including study design and analysis details, as well as study results.Performance Monitoring PlansIf a sponsor elects to employ proactive performance monitoring as a means of risk control and to provide safety and effectiveness assurances, the sponsor should include information regarding their performance monitoring plans.CybersecuritySponsors should include cybersecurity controls and security risk management relevant to the AI components or features.Public Submission SummaryFor most marketing authorization decisions, sponsors are required to provide public submission summaries. To support transparency, sponsors of AI-enabled devices should include in this summary specific information about device characteristics, such as descriptions of the statistical confidence level of predictions and descriptions of the development and validation datasets. Sponsors are encouraged to use model cards to organize this information (see Appendix E).TransparencyAppendix B contains recommendations for developing a transparent device around users, starting at the design phase of the TPLC. Reflecting the <a href="https://www.fda.gov/media/179269/download?attachment" target="_blank">2024 Joint Guiding Principles</a>, the draft guidance instructs sponsors to take a holistic approach to transparency, emphasizing that transparency should be considered during device design and throughout the full continuum of implementation. The draft includes examples of relevant considerations. Appendices E and F include examples of how to communicate information about a device’s AI model and the limitations of that device, based on FDA’s “user-centered research.” Performance Validation ConsiderationsAppendix C lists recommendations for clinical performance validation, such as pre-specifying study protocols and statistical analysis plans, as well as providing examples of when to conduct a precision study. This section also calls attention to scenarios leading to potential bias.<hr class="divider">[1] This section highlights examples of information that sponsors should include in a submission for an AI-Enabled Device. For a complete list, see U.S. Food & Drug Admin., Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations: Draft Guidance for Industry and Food and Drug Administration Staff (2025).

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Ashley E. Quinn is an associate in Morrison Foerster’s San Diego office.

Ashley E. Quinn

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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.

Brigid DeCoursey Bondoc

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.