FDA Regulatory and Compliance
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An Interdisciplinary Team Anchored by Former FDA Counsel
Wilson Sonsini’s Food and Drug Administration (FDA) regulatory attorneys possess firsthand agency experience, including from the Digital Health Center of Excellence, the Center for Devices and Radiological Health (CDRH), and the Center for Drug Evaluation and Research (CDER), and hold advanced scientific and public health degrees.
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Strategic Counsel for FDA-Regulated Businesses and Their Stakeholders
We represent innovators, founders, executives, investors, service providers, and other stakeholders across diverse industries, including life sciences, biotech, pharmaceuticals, generic drugs, medical devices, AI/ML-enabled medical technologies, mobile apps, diagnostics, research tools, healthtech, digital health, wellness, and consumer products.
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Comprehensive FDA Regulatory Counsel Across the Company Life Cycle
From preclinical research and development through commercial launch and exit, our attorneys work across the firm’s Corporate, Patents and Innovations, Technology Transactions, and Life Sciences practices to serve as both regulatory counsel and long-term strategic partners.
Wilson Sonsini's FDA regulatory attorneys counsel clients with respect to the full range of regulatory challenges that arise throughout a company's life cycle—from initial product development and clinical strategy through commercialization, corporate transactions, and post-market compliance.
Our attorneys advise companies across the full spectrum of FDA-regulated products and industries, including:
- Biologics and biosimilars
- Cell, tissue, and gene therapies
- Clinical decision support products and platforms
- Clinical Laboratory Improvement Amendments (CLIA) laboratories
- Combination products
- Cosmetics
- Dietary supplements
- Drugs and generics
- General wellness products
- Healthtech and digital health
- In-vitro diagnostics
- Research Use Only (RUO) products
- Medical devices
- Patient engagement tools and platforms
- Software as a medical device (SaMD)
The firm’s multidisciplinary team has practical experience in representing clients in regulatory FDA matters, including:
- Advertising and promotional review
- Compassionate use or expanded access requirements
- Citizen petitions
- Go-to-market strategy and business model review
- IDE, 510(k), De Novo, and PMA requirements
- IND, NDA, BLA, and ANDA requirements
- FDA compliance and enforcement
- FDA designation programs
- FDA regulation of clinical trials
- FDA regulatory exclusivities
- FDA regulatory risk mitigation strategies
- Orange Book listing
- Patent Term Restoration/Patent Term Extension
- Preparation for commercial launch, including manufacturer healthcare compliance programs
- Regulatory review of various contracts, including clinical trial agreements, supplier/contract manufacturer contracts, license agreements, and other commercial contracts
- Regulatory review of public disclosures
- Regulatory due diligence during corporate transactions, including financings, M&As, asset sales, and IPOs
- Strategies for expediting FDA review and approval
- Trade complaints to the FDA
- Transfer, sale, or change of ownership for FDA submissions/filings
Overview
Wilson Sonsini's FDA regulatory attorneys counsel clients with respect to the full range of regulatory challenges that arise throughout a company's life cycle—from initial product development and clinical strategy through commercialization, corporate transactions, and post-market compliance.
Our attorneys advise companies across the full spectrum of FDA-regulated products and industries, including:
- Biologics and biosimilars
- Cell, tissue, and gene therapies
- Clinical decision support products and platforms
- Clinical Laboratory Improvement Amendments (CLIA) laboratories
- Combination products
- Cosmetics
- Dietary supplements
- Drugs and generics
- General wellness products
- Healthtech and digital health
- In-vitro diagnostics
- Research Use Only (RUO) products
- Medical devices
- Patient engagement tools and platforms
- Software as a medical device (SaMD)
The firm’s multidisciplinary team has practical experience in representing clients in regulatory FDA matters, including:
- Advertising and promotional review
- Compassionate use or expanded access requirements
- Citizen petitions
- Go-to-market strategy and business model review
- IDE, 510(k), De Novo, and PMA requirements
- IND, NDA, BLA, and ANDA requirements
- FDA compliance and enforcement
- FDA designation programs
- FDA regulation of clinical trials
- FDA regulatory exclusivities
- FDA regulatory risk mitigation strategies
- Orange Book listing
- Patent Term Restoration/Patent Term Extension
- Preparation for commercial launch, including manufacturer healthcare compliance programs
- Regulatory review of various contracts, including clinical trial agreements, supplier/contract manufacturer contracts, license agreements, and other commercial contracts
- Regulatory review of public disclosures
- Regulatory due diligence during corporate transactions, including financings, M&As, asset sales, and IPOs
- Strategies for expediting FDA review and approval
- Trade complaints to the FDA
- Transfer, sale, or change of ownership for FDA submissions/filings
Alerts
CMS Proposes Payment Frameworks for “Software as a Medical Service”
On July 2, 2026, the Centers for Medicare and Medicaid Services (CMS) released the calendar year (CY) 2027 Hospital Outpatient Prospective Payment System (OPPS) proposed rule and on July 14, 2026, subsequently released the CY 2027 Physician Fee Schedule (PFS) proposed rule.1 These proposed rules establish a newly named Medicare payment category, Software as a Medical Service (SaMS), for software that supports clinical decision-making through algorithmic analysis.2 This is CMS’ first effort to pay for software-based clinical services in a structural way as their own category rather than as a cost buried inside reimbursement for another procedure. The consequential impact is that CMS would create a new reimbursement vehicle for software and AI-enabled products to be reimbursed as standalone services in the future. The proposal is worth close attention from stakeholders because Medicare reimbursement often determines the success of software or AI products intended for clinical purposes. Comments are due August 31, 2026, on the OPPS rule and September 14, 2026, on the PFS rule.
Press Releases
Wilson Sonsini Expands Healthcare Regulatory Practice with Brandon Ge and Ty Kayam
Contact:
Kimberly Brooks
212-453-2881
kbrooks@wsgr.com
Kimberly Brooks
212-453-2881
kbrooks@wsgr.com
Insights
Alerts
CMS Proposes Payment Frameworks for “Software as a Medical Service”
On July 2, 2026, the Centers for Medicare and Medicaid Services (CMS) released the calendar year (CY) 2027 Hospital Outpatient Prospective Payment System (OPPS) proposed rule and on July 14, 2026, subsequently released the CY 2027 Physician Fee Schedule (PFS) proposed rule.1 These proposed rules establish a newly named Medicare payment category, Software as a Medical Service (SaMS), for software that supports clinical decision-making through algorithmic analysis.2 This is CMS’ first effort to pay for software-based clinical services in a structural way as their own category rather than as a cost buried inside reimbursement for another procedure. The consequential impact is that CMS would create a new reimbursement vehicle for software and AI-enabled products to be reimbursed as standalone services in the future. The proposal is worth close attention from stakeholders because Medicare reimbursement often determines the success of software or AI products intended for clinical purposes. Comments are due August 31, 2026, on the OPPS rule and September 14, 2026, on the PFS rule.
Press Releases
Wilson Sonsini Expands Healthcare Regulatory Practice with Brandon Ge and Ty Kayam
Contact:
Kimberly Brooks
212-453-2881
kbrooks@wsgr.com
Kimberly Brooks
212-453-2881
kbrooks@wsgr.com
Eva F. Yin
Partner
Eva Yin, Ph.D., M.P.H., is a partner in Wilson Sonsini Goodrich & Rosati’s FDA regulatory, healthcare, and consumer products practice. Her practice includes conducting FDA and healthcare regulatory due diligence for corporate transactions; providing legal counsel to manufacturers regarding FDA approval/clearance for various products—including medical devices, mobile apps, and drugs, FDA compliance, regulation of promotional materials and labeling, and manufacturer compliance under federal and state healthcare laws, e.g., the federal Anti-Kickback Statute (AKS), False Claims Act (FCA), Sunshine Act, state licensing laws, corporate practice of medicine, etc.; reviewing contracts and compliance policies for manufacturers; and providing legal analysis and risk assessment of business models and fee arrangements involving patient assistance programs, healthcare professionals, or hospitals/clinics under federal and state healthcare laws and regulations.
Jodi Daniel
Partner
Jodi Daniel is a nationally recognized leader in digital health law and policy, trusted by health care organizations and technology innovators to navigate the complex and dynamic regulatory landscape of digital health and wellness. With over 30 years of experience in healthcare innovation—including 15 years as a lawyer and senior policymaker at the U.S. Department of Health and Human Services (HHS)—Jodi leverages her extensive experience in digital health and health data to deliver strategic, practical advice to clients engaged in groundbreaking products and services that raise novel legal, policy, and ethical issues.
Ty Kayam
Of Counsel
Ty Kayam is Of Counsel in the Seattle office of Wilson Sonsini Goodrich & Rosati, where she advises companies and investors on regulatory strategy for health technology products, with a particular focus on health AI, digital health, wearables, medical robotics, and health data infrastructure. She counsels clients throughout product development and commercialization and advises on health regulatory issues arising in financings, investments, partnerships, and strategic transactions. Her practice draws on experience at the FDA, Microsoft, and a national health information network, combining regulatory insight, technical fluency, and a systems-level understanding of how health technologies are developed, deployed, and scaled.
Daniel E. Orr
Senior Counsel
Dan Orr is senior counsel at Wilson Sonsini Goodrich & Rosati, where he brings an insider’s perspective to helping clients prevent and solve problems with the U.S. Food & Drug Administration. Dan, a former FDA regulatory counsel, has more than 20 years of experience concerning regulation of drugs, biologics, and medical devices.
People
Eva F. Yin
Partner
Eva Yin, Ph.D., M.P.H., is a partner in Wilson Sonsini Goodrich & Rosati’s FDA regulatory, healthcare, and consumer products practice. Her practice includes conducting FDA and healthcare regulatory due diligence for corporate transactions; providing legal counsel to manufacturers regarding FDA approval/clearance for various products—including medical devices, mobile apps, and drugs, FDA compliance, regulation of promotional materials and labeling, and manufacturer compliance under federal and state healthcare laws, e.g., the federal Anti-Kickback Statute (AKS), False Claims Act (FCA), Sunshine Act, state licensing laws, corporate practice of medicine, etc.; reviewing contracts and compliance policies for manufacturers; and providing legal analysis and risk assessment of business models and fee arrangements involving patient assistance programs, healthcare professionals, or hospitals/clinics under federal and state healthcare laws and regulations.
Jodi Daniel
Partner
Jodi Daniel is a nationally recognized leader in digital health law and policy, trusted by health care organizations and technology innovators to navigate the complex and dynamic regulatory landscape of digital health and wellness. With over 30 years of experience in healthcare innovation—including 15 years as a lawyer and senior policymaker at the U.S. Department of Health and Human Services (HHS)—Jodi leverages her extensive experience in digital health and health data to deliver strategic, practical advice to clients engaged in groundbreaking products and services that raise novel legal, policy, and ethical issues.
Ty Kayam
Of Counsel
Ty Kayam is Of Counsel in the Seattle office of Wilson Sonsini Goodrich & Rosati, where she advises companies and investors on regulatory strategy for health technology products, with a particular focus on health AI, digital health, wearables, medical robotics, and health data infrastructure. She counsels clients throughout product development and commercialization and advises on health regulatory issues arising in financings, investments, partnerships, and strategic transactions. Her practice draws on experience at the FDA, Microsoft, and a national health information network, combining regulatory insight, technical fluency, and a systems-level understanding of how health technologies are developed, deployed, and scaled.
Daniel E. Orr
Senior Counsel
Dan Orr is senior counsel at Wilson Sonsini Goodrich & Rosati, where he brings an insider’s perspective to helping clients prevent and solve problems with the U.S. Food & Drug Administration. Dan, a former FDA regulatory counsel, has more than 20 years of experience concerning regulation of drugs, biologics, and medical devices.
Recent Insights
Alerts
CMS Proposes Payment Frameworks for “Software as a Medical Service”
On July 2, 2026, the Centers for Medicare and Medicaid Services (CMS) released the calendar year (CY) 2027 Hospital Outpatient Prospective Payment System (OPPS) proposed rule and on July 14, 2026, subsequently released the CY 2027 Physician Fee Schedule (PFS) proposed rule.1 These proposed rules establish a newly named Medicare payment category, Software as a Medical Service (SaMS), for software that supports clinical decision-making through algorithmic analysis.2 This is CMS’ first effort to pay for software-based clinical services in a structural way as their own category rather than as a cost buried inside reimbursement for another procedure. The consequential impact is that CMS would create a new reimbursement vehicle for software and AI-enabled products to be reimbursed as standalone services in the future. The proposal is worth close attention from stakeholders because Medicare reimbursement often determines the success of software or AI products intended for clinical purposes. Comments are due August 31, 2026, on the OPPS rule and September 14, 2026, on the PFS rule.
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