Overview
Vernessa Pollard works alongside life sciences, medical device and technology companies, helping them navigate US Food and Drug Administration (FDA) regulatory complexities 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, she helps clients develop practical, scalable and innovative strategies for solving challenging regulatory and compliance problems, evaluating risk and achieving business objectives. Vernessa is co-head of the Firm’s global Life Sciences practice and also leads the FDA practice.
Vernessa is a thought-leader on digital health and regulatory issues involving clinical decision support (CDS) and software as a medical device (SaMD). For medical device, technology and biotech companies, she provides strategic business and regulatory advice on premarket strategy, including product development, post-market compliance and regulatory issues, from manufacturing and quality to advertising and promotion.
Using her experience and insight as a former Associate Chief Counsel for Enforcement in FDA’s Office of Chief Counsel, Vernessa helps companies engage with the agency and align internal processes to address regulatory, compliance and business goals. During her tenure 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 in the FDA Center for Devices and Radiology Health (CDRH) and others to review and evaluate warning letters, compliance policies and regulatory actions. Vernessa obtained the organization’s first administrative civil money penalty (CMP) judgment to enforce Medical Device Report (MDR) requirements.
Vernessa is a recognized leader, with numerous accolades, in the life sciences community and is extremely engaged in the life sciences legal space, most recently serving as a co-chair of the Food and Drug Law Institute’s (FDLI) 2022 Annual Conference. She is also a founder and board member of MedTech Color, a 501(c)3 nonprofit organization that aims to advance the representation of people of color in the medical device industry.
Results
- Advised the developer of AI-enabled software for neuro-muscular disorders on FDA device classification and premarket strategy, including a review of the successful application for breakthrough device designation.
- Guided a global medical device manufacturer to avoid FDA enforcement action related to marketing and labeling claims, including the development of a FDA engagement strategy, corrective action plan and corrective communications.
- Advised a global technology company on the development of new smart phone technology with diagnostic applications and software, including predicate and classification analysis, strategy for digital health technical master file, and successful regulatory meetings with FDA officials on go-to-market strategy.
- Guided global pharmaceutical companies on regulatory strategy for digitally enabled companion software and mobile applications to support prescription drug products.
- Developed FDA regulatory strategy for early stage developer of augmented eyewear device, including preparation for FDA regulatory meeting, review of regulatory submissions, assistance with refinement of quality management systems, analysis of warranty and warning protocols, and development of marketing strategy and collateral.
Recognitions
- Profiles in Diversity Journal, Women Worth Watching in Leadership, 2021
- Chambers USA, Healthcare: Pharmaceutical/Medical Products Regulatory (District of Columbia), 2014 to 2022
- Thomson Reuters, Stand-out Lawyer – independently rated lawyers, 2023
- LMG Life Sciences, Regulatory Attorney of the Year: FDA Medical Devices, 2018 and 2020
- LMG Life Sciences, Life Science Star, 2015, 2016, 2018
- Who’s Who Legal: Healthcare 2021
- The Best Lawyers in America, FDA Law, 2015 to 2021
- Who’s Who Legal: Life Sciences 2021
- Savoy Magazine, “Most Influential Black Lawyers,” 2018
- The Legal 500 USA, 2017, 2019
- The National Law Journal, DC Rising Star (2014), Minority 40 Under 40 (2011), FDA Commissioner’s Award of Excellence (2008)
- US Department of Health & Human Services Secretary’s Award for Distinguished Service, FDA Ephedra Rulemaking and Litigation, 2005
- FDA Commissioner’s Outstanding Service Award for Outstanding Legal Representation and Dedication in Conducting Enforcement and Defensive Litigation, 2005
Community
- American Health Lawyers Association, FDA Regulatory Affinity Group, chair, 2014 to 2015
- American Health Lawyers Association, FDA Regulatory Subcommittee, Life Sciences Committee, chair, 2014 to 2017
- Food and Drug Law Institute, Medical Devices and Diagnostics Committee, co-chair, 2014 to 2017.
- Food and Drug Law Institute, Medical Products Advisory Committee, member
- Temple Political and Civil Rights Law Review, managing editor, 1999
Credentials
Education
Temple University Beasley School of Law, JD, 1999
Howard University, BA, cum laude, 1996
Admissions
District of Columbia
New Jersey
Pennsylvania
