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Vernessa Pollard

Socia

Co-Chair, FDA Regulatory practice

Vernessa is knowledgeable and collaborative.  A true dynamo of a lawyer.
— Client Feedback, Chambers
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 FocusCiencias de la vida
Bar admissionsDistrito de ColumbiaNew JerseyPennsylvania
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

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

  • J.D., Temple University - James E. Beasley, School of Law 1999

  • B.A., Howard University 1996

AWARDS

Chambers USA

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

The Legal 500 United States

  • Leading Lawyer, Life Science (2024)
Additional Awards
  • 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 and media

  • Author, "How FDA Really Works: Insights from the Experts," Chapter 6: 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
  • Moderator, 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," Medical Device Manufacturer’s Association (MDMA) Annual Meeting, April 27, 2023

Prior Experience

Prior to joining DLA Piper, Vernessa was the Chair of the FDA Regulatory Practice at 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 FDA and other law firms.

Memberships and Affiliations

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

My latest insights

Publication

FDA issues Platform Technology Designation Program for Drug Development draft guidance

10 de junio de 2024 .8 minute read

Publication

FDA Regulatory News and Trends - May 14, 2024

14 de mayo de 2024 .8 minute read

Publication

FDA Regulatory News and Trends - April 29, 2024

29 de abril de 2024 .9 minute read

View All

Connect

Phone

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