Digital Health and AI Technologies

AI and the FDA

Artificial intelligence (AI) and machine learning (ML) have opened the door to revolutionary changes in the life sciences industry. AI is having a transformative impact on the ways in which the Food and Drug Administration (FDA) and FDA-regulated entities approach the development, manufacturing, use, and oversight of medical products.

How We Add Value

Our lawyers draw on their vast experience working with FDA and unparalleled industry know-how to help guide clients through the shifting AI regulatory landscape. Sidley’s Food, Drug and Medical Device (FDMD) Regulatory Team has experience advising clients on the uses of AI throughout a product’s life cycle, including how products are developed, manufactured, and monitored. With its global platform and cross-disciplinary approach, Sidley is well positioned to help clients embrace opportunities, navigate uncertainties, prepare for, and share their thought leadership on emerging regulatory frameworks.

Representative Matters

We provide a range of services related to FDA’s approach to AI, including:

Counseling biopharmaceutical companies on potential FDA regulation of software functions and AI technologies used in clinical trials
Advising consumer health companies and systems on specific carve-outs in FDA law for certain software functions using AI technologies to support physicians
Counseling clients on informed consent considerations when AI is used in a clinical setting
Advising life sciences companies on AI governance policies, including the use of generative AI/large language models (LLMs)
Conducting multi-jurisdictional reviews of AI regulatory developments for global multinationals
Advising consumer health entities on the use of images generated with AI in marketing materials
Guiding pharmaceutical and medical device clients through FDA regulatory approval, clearance, or authorization and reimbursement considerations for products using AI
Advising on the uses of AI in pharmacovigilance
Counseling clients on the deployment and implementation of AI to strengthen manufacturing compliance and supply chain efficiency
Supporting clients on AI-related regulatory issues for mergers and acquisitions, asset purchase agreements, licensing, lending, securities offerings, and other transactional matters
Advising on the use and role of third parties (e.g., voluntary standards, certifications, and use of foundation models)

Sidley Thought Leadership