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FDA Publishes Draft Guidance for Predetermined Change Control Plan for AI/ML-Enabled Device Software Functions

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On April 3, 2023, FDA released the draft guidance titled “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions”

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On April 3, 2023, FDA released the draft guidance titled “<a href="https://www.fda.gov/media/166704/download" target="_blank">Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions</a>” (hereinafter “draft guidance”) proposing an approach to support iterative improvement through modifications to a machine learning device software function (ML-DSF) while continuing to provide reasonable assurance of device safety and effectiveness. FDA is accepting <a href="https://www.regulations.gov/docket/FDA-2022-D-2628" target="_blank">comments</a> on the draft guidance until July 3, 2023. Read the <a href="https://lifesciences.mofo.com/topics/fda-publishes-draft-guidance-for-predetermined-change-control-plan-for-ai-ml-enabled-device-software-functions" target="_blank">full blog post</a>.

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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.As a member 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

Brandy Guarda is a regulatory analyst supporting the FDA + Healthcare Regulatory and Compliance practice in Morrison Foerster’s Washington, D.C. office. Brandy predominantly focuses on researching and tracking FDA and interagency regulatory guidance, proposed and final rules, legislation, and enforcement actions.Brandy provides clients with insights on the developing regulatory and policy landscape for FDA-regulated products, tracks Anti-Kickback Statute and other fraud and abuse developments, and tracks healthcare policy and legislative developments, including the Inflation Reduction Act.Brandy has extensive experience and can offer specialized assistance in FDA and healthcare matters. Her qualifications and skills are described in more detail below.<h5>Dietary Supplements/Food</h5><ul><li>Certified in regulatory compliance for dietary supplements and natural health products, including 21 C.F.R. 111 (Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements).</li><li>Certified to evaluate evidence used in claims substantiation.</li><li>Supports clients by tracking and monitoring FDA regulatory and enforcement actions on unapproved, adulterated, or misbranded dietary supplements and food, including baby food and infant formula.</li><li>Tracks regulatory and legislative developments impacting the sale and marketing of dietary supplements, including state initiatives.</li></ul><h5>Pharmaceutical & OTC Drugs</h5><ul><li>Reviews and analyzes advertising and promotional claims, including for unapproved uses.</li><li>Supports clients by tracking and monitoring FDA regulatory and enforcement actions on unapproved, adulterated, or misbranded drugs, including OTC and homeopathic drugs.</li><li>Supports clients by tracking and monitoring OTC monographs.</li><li>Provides research and analysis on drug approval precedents, including under the 505(b)(1) and 505(b)(2) pathways, Orange Book listings, and expedited review programs.</li></ul><h5>Medical Devices</h5><ul><li>Reviews and analyzes advertising and promotional claims, including for unauthorized uses.</li><li>Supports clients by tracking and monitoring FDA regulatory and enforcement actions on unapproved, adulterated, or misbranded medical devices.</li><li>Analyzes Software as a Medical Device (SaMD), Digital Health Technologies (DHTs), and Laboratory Developed Tests (LDTs), including precedent and policies.</li><li>Analyzes publicly available data on precedents, adverse events, and competitor products.</li></ul><h5>Cosmetics</h5><ul><li>Reviews and analyzes advertising and promotional claims.</li><li>Supports clients by tracking and monitoring FDA regulatory and enforcement actions on unapproved, adulterated, or misbranded cosmetics.</li><li>Tracks implementation of the Modernization of Cosmetics Regulation Act (MoCRA).</li></ul><h5>Certificate Courses</h5><ul><li>Regulatory Affairs Professionals Society® (Regulation of Dietary Supplements and NHPs)</li><li>EAS Consulting Group (Dietary Supplement Good Manufacturing Practices)</li><li>EAS Consulting Group (Dietary Supplements Claims Substantiation)</li></ul>Prior to joining MoFo, Brandy supported two other FDA and healthcare legal practices. Brandy’s work focused heavily on inspection preparations, DOJ investigations, regulatory inquiries, FDA submissions, and summarizing legislative updates from congressional hearings.