Vernessa Pollard

Partner
Chair, FDA Regulatory Practice
Vernessa Pollard at DLA Piper is a fantastic partner in this industry...She always leads with a business perspective. She is so knowledgeable with the FDA and the working[s] of the agency that her expertise is incredibly valuable.
— Client quoted in Chambers USA
Washington, DC
About

Vernessa Pollard advises life sciences, medical device, and technology companies, helping them navigate US Food and Drug Administration (FDA) regulatory and compliance issues to bring novel technologies and cutting-edge products to market. As a trusted advisor and legal strategist for multi-national life science companies, start-ups, and investors, Vernessa helps clients develop practical, scalable, and innovative strategies for solving challenging regulatory and compliance problems – evaluating risk and achieving business objectives.

For medical device, technology, and biotech companies, she provides strategic business and regulatory counsel regarding premarket strategy, including product development, post-market compliance, and regulatory matters that range from manufacturing and quality to advertising and promotion.

Vernessa previously served as Associate Chief Counsel for Enforcement in the FDA's Office of Chief Counsel, where she represented the FDA on a variety of regulatory, litigation and enforcement matters involving issues ranging from advertising, medical device and drug manufacturing to clinical trial compliance and product safety. She worked closely with compliance and regulatory personnel across FDA, including FDA's Center for Devices and Radiology Health (CDRH), to review and evaluate warning letters, compliance policies and regulatory actions.

Areas of FocusFDA RegulatoryLife Sciences
Vernessa Pollard is the best attorney, bar none, at melding legal expertise with practical guidance. She has been my go-to outside counsel for … regulatory matters and, specifically, emerging issues in digital health. [S]he has been brilliant at helping navigate the unknowns and anticipating potential risks. She is an expert on the FDA regulatory framework and its application to new technologies, and she is almost prescient at predicting the agency's future direction due to her experience in and outside of the government.
— Client quoted in Chambers USA
Vernessa Pollard is a highly skilled healthcare attorney who provides excellent legal advice. She responds to inquiries very quickly and her guidance is practical.
— Client feedback from The Legal 500 United States

EXPERIENCE

  • Outside counsel to multiple public medical device and biotech companies on internal investigations and implementation of continuous improvement programs arising from FDA regulatory issues including quality, recalls and safety issues
  • Strategic advisor to multiple public technology companies on the regulatory and business strategies for the development and commercialization of digital health solutions, software-as-a-medical device (SaMD) and AI-enabled diagnostic and digital therapeutic products
  • Representation of global pharmaceutical and medical device manufactures in negotiations of FDA Consent Decrees, resolutions of Warning and Untitled Letters and responding to FDA and competitor inquiries regarding marketing and promotion of medical and consumer products
  • Trusted advisor to leading venture capital and private equity firms on life sciences portfolio strategies, risk assessments, due diligence, and engagement with key regulators
Education

    AWARDS AND RECOGNITIONS

    Chambers USA

    • Band 1, District of Columbia Healthcare: Pharmaceutical/Medical Products Regulatory, (2024 – 2025)

    The Legal 500 United States

    • Leading Partner, Life Science, (2024 – 2025)
    Government Service Recognitions
    • Award of Excellence, FDA Commissioner, (2008)
    • Secretary's Award for Distinguished Service, FDA Ephedra Rulemaking and Litigation, US Department of Health & Human Services, (2005)
    • Outstanding Service Award, Outstanding Legal Representation and Dedication in Conducting Enforcement and Defensive Litigation, FDA Commissioner, (2005)
    Additional Recognitions
    • Stand Out Lawyer, Thomson Reuters, (2023)
    • MedTech Color Champion, MedTech Color, (2023)
    • Women Worth Watching in Leadership, Profiles in Diversity Journal, (2021)
    • Who's Who Legal, (2021)
    • Regulatory Attorney of the Year: FDA Medical Devices, LMG Life Sciences, (2018, 2020)
    • Life Science Star, LMG Life Sciences, (2015 – 2016, 2018)

    Publications

    • Author, Chapter 6: "How FDA Really Works: Insights from the Experts," Practical Strategies for Engaging with FDA on Medical Device and Digital Health Issues, Food and Drug Law Institute, July 2022

    Seminars

    • "Addressing Bias in Artificial Intelligence/Machine Learning for Medical Devices," MedTech Conference, October 11, 2023
    • "Equity in Pediatric Medical Device Access," Children's National, Pediatric Device Innovation Symposium, October 8, 2023
    • "Driving Inclusive Design as the New Gold Standard," MedTech Vision Conference, September 12, 2023
    • "Why MedTech: Practical Strategies to Implement DE&I in the Medtech Workplaces," MassMEDIC Webinar, August 24, 2023
    • Director's Update: Center for Devices and Radiological Health (CDRH), FDLI Annual Conference, May 17, 2023
    • NIH Innovative Approaches to Improve Maternal Health Workshop, NIH IMPROVE and NIH SEED, May 8, 2023
    • "Diversity in Medtech," Annual Meeting, Medical Device Manufacturers Association (MDMA), April 27, 2023

    Prior Experience

    Prior to joining DLA Piper, Vernessa was the Chair of the FDA Regulatory Practice at another global law firm, co-chair of the global life sciences industry practice and member of the firm's management committee. Vernessa has over 20 years of experience in FDA regulatory law, including legal roles at the FDA and other law firms.

    Memberships and Affiliations

    • Vice Chair, Board of Directors, Food and Drug Law Institute, (2023)
    • Co-founder and Secretary, Board of Directors, MedTech Color
    • Executive Planning Committee, MedTech Color Collaborative Community
    • Advisory Board, MedTech MVP

    My latest insights

    Publication

    Presidential Memorandum on DTC prescription drug advertising signals increased focus on...

    12 September 2025 .12 minute read

    Publication

    Make Our Children Healthy Again Assessment: Unpacking the report

    30 May 2025 .13 minute read

    Past event

    Unpacking the Make America Healthy Again report

    23 May 2025 .1 minute read

    View All

    Connect

    Phone

    +1 202 799 4212
    (Work, Washington, DC)
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