
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.
Experience
- 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.
viewpoints
The AI Search Engine Doctor Is Always In: What Are the Regulatory and Legal Implications?
March 14, 2023 | Blog | By Benjamin Zegarelli, Daniel Herling
FDA’s Digital Health High Notes from 2022
February 13, 2023 | Blog | By Benjamin Zegarelli
Mintz Health Law: What We Are Grateful For
January 11, 2023 | Podcast | By Bridgette Keller
Regulatory Roundup: Important FDA Developments at the End of September 2022
October 10, 2022 | Blog | By Joanne Hawana , Benjamin Zegarelli
FDA Is Accepting EUA Requests for Monkeypox Tests, But Time is of the Essence
September 28, 2022 | Blog | By Benjamin Zegarelli, Joanne Hawana
Recent FDA Warning Letter to Amazon.com Suggests the Agency Is Getting Tired of the Whack-a-Mole Game
August 22, 2022 | Blog | By Joanne Hawana , Benjamin Zegarelli
FDA’s Review of Pulse Oximeter Performance Continues a Trend in Addressing Biases in Digital Health Technologies
July 12, 2022 | Blog | By Benjamin Zegarelli
Summer 2022 Is Here – Do You Know How the FDA User Fee Legislation Is Going?
June 2, 2022 | Blog | By Joanne Hawana
FDA Cracks Down on Unauthorized and Counterfeit COVID-19 Diagnostic Tests
May 9, 2022 | Blog | By Benjamin Zegarelli
News & Press
Mintz Advises Underwriters of Viking’s $287.5 Million Public Offering of Common Stock
April 10, 2023
Mintz Advises NexImmune in its Upsized $126.5 Million IPO
February 17, 2021
Introduction to the Due Diligence Process
July 27, 2020
What FDA Has Done So Far In Response To COVID-19
April 1, 2020
To Pitch Pre-Cert to Congress, FDA Builds a Case First
September 26, 2019
Health Care Enforcement Review And 2017 Outlook: Part 1
January 13, 2017
GE Salmon Sets Stage For Future GMO Labeling Regime
June 27, 2016
Food Companies Are Hedging Their Bets With GMO Labeling
April 25, 2016
Events & Speaking
Clarifying the Clinical Trials Process for Drugs and Biologics
ACI's 40th FDA Boot Camp
Virtual Conference

Everything Life Sciences Companies Need to Know to Navigate the COVID-19 Pandemic
View the Webinar Recording

Mount Sinai Innovation Partners Lecture
Protecting and Commercializing Your Innovation – FDA Regulation
New York, NY
Recognition & Awards
- Best Lawyers in America "Ones to Watch": Administrative / Regulatory Law (2021-2022); Health Care Law (2021-2022)