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 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.

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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.

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Recognitions


  • Chambers USA, Healthcare: Pharmaceutical/Medical Products Regulatory (District of Columbia), 2014 to 2020
  • LMG Life Sciences, Regulatory Attorney of the Year: FDA Medical Devices, 2018 and 2020
  • LMG Life Sciences, Life Science Star, 2015, 2016, 2018

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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.

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Credentials


Education
Temple University Beasley School of Law, JD, 1999
Howard University, BA, cum laude, 1996

Admissions
District of Columbia
New Jersey
Pennsylvania

Vernessa T. Pollard

Insights & Events / Media

Webinar / Speaking Engagements / October 28, 2020

Virtual Event / McDermott Event / October 20 - November 17, 2020

Webinar / Speaking Engagements / August 19, 2020

Shanghai, China / McDermott Event / November 12, 2019

Boston, Massachusetts / Speaking Engagements / September 24, 2019

Boston, Massachusetts / Speaking Engagements / September 22, 2019

San Francisco, CA / McDermott Event / July 18, 2019

Podcasts / June 26, 2019

Washington, DC / Speaking Engagements / April 30, 2019

On the Subject / March 18, 2019

Special Report / January 7, 2019

Cambridge, Massachusetts / McDermott Event / September 12, 2018

On the Subject / June 15, 2018

Washington, District of Columbia / Speaking Engagements / May 3-4, 2018

Special Report / February 8, 2017

On the Subject / January 31, 2017

Special Report / January 19, 2017

San Francisco, California / McDermott Event / January 10, 2017

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