Benjamin provides counsel on compliance and regulatory issues to clients in the pharmaceutical, medical device, and biotech industries. With a clear focus on FDA regulatory counseling, Benjamin advises a breadth of health care industry clients, including pharmaceutical, medical device, and bio tech companies, on the federal and state laws surrounding medical product development and marketing. He has extensive experience guiding medical device companies through the FDA regulatory process to identify the correct regulatory pathway, assisting with communications and meetings with FDA, ensuring that regulatory submissions meet regulatory requirements, and helping to establish robust post-market quality system and compliance controls. In particular, Benjamin has counseled numerous medical device software developers, in particular software that includes artificial intelligence or machine learning functionalities, on FDA regulatory strategy, including preparing for pre-submission meetings with FDA and submitting premarket notifications (510(k)) and de novo reclassification requests. His practice also includes advising life sciences clients on regulatory compliance relating to distribution, sales, promotion, and negotiating contractual relationships with suppliers and other contractors.
Benjamin has substantial experience representing medical device companies in responding to significant unfavorable observations from FDA investigators, including regulatory violations cited in Untitled Letters or Warning Letters. He helps companies with compliance issues to navigate the process of communicating with FDA and remediating the identified compliance issues, including the development of corrective action plans and implementation of corrective and preventive actions.
In his practice, Benjamin participates in the coordination of diligence reviews of transactions involving large pharmaceutical and medical device manufacturers. He is well versed in the process of developing policy positions for life sciences clients and advocating such positions before FDA or other governmental bodies through written comments or in-person meetings . His practice also includes representing both clinical trial sponsors and clinical sites on clinical research issues, including government grant regulations, as well as drafting and negotiating the agreements necessary to perform clinical research.
Benjamin has co-authored several books titled, Promotion of FDA-Regulated Medical Products and Introduction to the Due Diligence Process, Second Edition, both published by the Regulatory Affairs Professional Society. He has given numerous presentations on current health care industry topics, with titles such as Advertising and Promotion for Drugs, Devices and Biologics Using Social Media and Promotion of Investigational Drugs and Devices. He previously worked as a research chemist in the discovery group of a major research-based health care and pharmaceutical company. While in law school, he held the position of Executive Editor of the Cardozo Law Review.
- Benjamin N. Cardozo School of Law (JD, cum laude)
- California Institute of Technology (MS, Synthetic Organic Chemistry)
- Middlebury College (BA, Chemistry, summa cum laude)
- Worked with several Mintz clients operating in non-FDA regulated industries to determine how to manufacture and distribute face masks and alcohol-based hand sanitizers in compliance with FDA's enforcement discretion policies during the COVID-19 pandemic, including by providing promotion and labeling advice.
- Counseled multiple Mintz clients developing in vitro diagnostic tests for SARS-CoV-2 on compliance with FDA’s enforcement discretion and EUA policies during the COVID-19 pandemic, including assistance with promotion and clinical testing activities.
- Assisted a pharmacogenetics software company with drafting a pre-submission meeting briefing documents, attended the pre-submission meeting with the client and FDA, and counseled the client on drafting a marketing authorization application that addressed the issues discussed at the pre-submission meeting.
- Advised multiple Mintz clients developing medical device software on selecting the most appropriate regulatory strategy for their products in light of contemporary FDA software policies and guidance and avoiding potential regulatory pitfalls relating to software design, quality controls, and pre-market submissions.
- Provided extensive assistance to a major medical device manufacturer in responding to regulatory observations from multiple FDA inspections and enforcement actions, including a Warning Letter and a regulatory meeting, including development of a corrective action plan, assisting with the implementation and effectiveness evaluation of corrective and preventive actions, and auditing the company’s complaint handling and MDR reporting systems.
- Collaborated with ML Strategies to develop a comprehensive strategy to advocate FDA and Congress for development and implementation of regulatory oversight for third-party servicers of medical devices on behalf of a major medical device manufacturer.
Recognition & Awards
- Best Lawyers in America "Ones to Watch": Administrative / Regulatory Law (2021); Health Care Law (2021)
October 29, 2020 |Blog
News & Press
October 29, 2020 | Blog | By Bridgette Keller, Benjamin Zegarelli
September 16, 2020 | Blog | By Bridgette Keller, Benjamin Zegarelli
September 2, 2020 | Video | By Elizabeth Conti
June 10, 2020 | Blog | By Benjamin Zegarelli, Elizabeth Conti, Joanne Hawana
May 8, 2020 | Blog | By Benjamin Zegarelli, Elizabeth Conti
May 4, 2020 | Blog | By Benjamin Zegarelli, Elizabeth Conti
April 7, 2020 | Blog | By Benjamin Zegarelli
FDA Creates Regulatory Exemptions for Face Masks and Respirators in Response to the Spread of COVID-19 and Critical PPE Shortages
March 27, 2020 | Blog | By Benjamin Zegarelli
March 21, 2020 | Blog | By Dianne Bourque, Benjamin Zegarelli
March 18, 2020 | Blog | By Joanne Hawana, Aaron Josephson, Benjamin Zegarelli
We published our first installment highlighting FDA’s role in this public health emergency on March 4, 2020 (see our prior post here). In the two weeks that have elapsed since then, FDA has taken several actions related to COVID-19 testing and other important public health protections which are explained below. One of the most striking things about the list of actions included in this post may be how diverse and broad FDA’s authorities are and what a substantial role the agency plays in protecting Americans from a variety of different types of harm.