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Benjamin M. Zegarelli

Of Counsel

[email protected]

+1.212.692.6261

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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.
 

 

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viewpoints

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Regulatory Roundup: Important FDA Developments at the End of September 2022

October 10, 2022 | Blog | By Joanne Hawana, Benjamin Zegarelli

There were so many interesting and significant developments related to the various missions of the U.S. Food and Drug Administration (FDA) during the last week or so of September 2022 that we decided to create a summary roundup for our readers!
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FDA Is Accepting EUA Requests for Monkeypox Tests, But Time is of the Essence

September 28, 2022 | Blog | By Benjamin Zegarelli, Joanne Hawana

The Food and Drug Administration (FDA) issued a guidance on development and emergency use authorization of diagnostic and serological tests for the monkeypox virus following the Secretary of the Department of Health and Human Service’s declaration of a public health emergency under Section 564 of the Food, Drug and Cosmetic Act on August 9, 2022. Subsequently, the Secretary declared on September 7 that in vitro diagnostics for monkeypox were needed to respond to the public health emergency, and the FDA released its guidance on the same day. The monkeypox test guidance describes the agency’s general expectations and approach for test development and validation, as well as the EUA request process.
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Receiving a warning letter from the U.S. Food and Drug Administration (FDA) means that the agency has identified what it calls “violations of regulatory significance” and that you (as the recipient) need to take corrective actions or risk inviting some actual enforcement under the Food, Drug, and Cosmetic Act (FD&C Act), which could include injunctions, seizures, and criminal penalties. This post highlights what an FDA warning letter means for Amazon.com as well as potential implications for the retail giant. 
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The U.S. Food and Drug Administration (FDA) will schedule a public meeting of the Medical Devices Advisory Committee later this year to discuss study results, real-world data, and other evidence concerning the accuracy and performance of pulse oximeters. The planned meeting is consistent with the agency’s recent efforts to evaluate the need for and options to address transparency and diversity in the design and development of artificial intelligence/machine learning (AI/ML) based software devices (see our post covering FDA’s Transparency of AI/ML Enabled Medical Devices Workshop) and in clinical trial design. It is unclear whether or how the outcome of the planned meeting on pulse oximeters will affect prescription and over-the-counter (OTC) pulse oximeters currently on the market, but it is possible that the meeting could lead FDA to impose new testing or labeling requirements for pulse oximeters, and perhaps even other devices that use light-based sensors to evaluate certain biometrics.
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Anyone who has spent any time around health care policymaking circles in Washington, D.C. has heard about the intense five-year cycle Congress goes through in order to reauthorize the biggest user fee programs at the Food and Drug Administration (FDA). Mintz previously published this wonderful explanation of the process complete with an estimated timeline for how this year’s reauthorization was likely to go. As a reminder, the current authorization for FDA’s various human product user fee programs – with the exception of the over-the-counter drug program that was freshly created in 2020 – will expire on September 30, 2022 with the end of the federal government’s fiscal year, unless they are renewed by Congress before that time.
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As the COVID-19 public health emergency drags into its third year, we continue to keep track of efforts by the Food and Drug Administration (FDA) to combat fraud in the form of fake cures, counterfeit diagnostic tests, and other products claiming to prevent, treat, or detect infection by SARS-CoV-2 that are marketed without required FDA authorization. Our previous posts provided updates on joint and separate efforts by FDA and the U.S. Federal Trade Commission (FTC) throughout the pandemic to detect and eliminate these illegal products. In this post, we focus on FDA’s recent enforcement activities concerning COVID-19 diagnostic tests and the agency’s increasingly aggressive pursuit of entities offering counterfeit or unauthorized tests.
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In this episode of the Health Law Diagnosed podcast, members of the Mintz Health Law team discuss their health law–focused 2022 New Year’s resolutions and how they’re helping clients and colleagues navigate the continued challenges and opportunities of the current era.
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Snapshot of Another Much-Too-Busy Year for FDA Before 2022 Really Gets Started

January 5, 2022 | Blog | By Joanne Hawana, Benjamin Zegarelli

It is, somewhat amazingly, the beginning of January again. During this time of year we typically publish a series of blog posts that recap the most interesting Food and Drug Administration (FDA) activities over the prior 12 months and consider what the agency is likely to focus on going forward. This year, however, we’re taking a different approach and will be providing more of a birds-eye view of our favorite federal agency as it stands as of the end of 2021. Because there is just too much going on at the administrative, enforcement, and legislative levels to get into the details of everything in one fell swoop. So make sure you’re signed up for Mintz Health Law Viewpoints to receive updates throughout the year on issues as they develop.
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On December 22, 2021, FDA took another step in rolling back enforcement policies implemented in response to the COVID-19 pandemic by publishing guidance documents describing the regulatory requirements for devices that were authorized under the emergency use authorization process and those under temporary FDA policies implementing specific enforcement discretion during the pandemic once the Public Health Emergency for COVID-19 ends. The Transition Plan Guidances will help device manufacturers prepare for the end of the PHE and continue to commercialize devices necessary for the long-term response to COVID-19.
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About Face: Laboratory-Developed Tests for COVID-19 Now Subject to EUA Requirements

November 19, 2021 | Blog | By Joanne Hawana, Benjamin Zegarelli

For over a year now, there has been speculation about how the Biden Administration would handle the chronically vexing regulatory issues associated with laboratory-developed tests (LDTs). On November 15, 2021 we finally got our answer when the August 2020 policy put in place by the Trump Administration was officially withdrawn. The Food and Drug Administration (FDA) also released corresponding updates to various guidelines related to the testing response to the ongoing public health emergency. Before summarizing all of these critically important developments, we’ll provide some quick history of what has been going on with LDTs since the pandemic began.
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News & Press

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Mintz Member Joanne Hawana, Senior Director of ML Strategies Aaron Josephson, and Mintz Associate Benjamin Zegarelli co-authored an article published in Law360 discussing the latest actions from the U.S. Food and Drug Administration (FDA) in response to COVID-19.
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MedTechDive reported that the U.S. Food and Drug Administration is not yet ready to go to Congress to seek new powers for its evolving precertification pilot for software, but it will need new authorities to determine how the experimental path fits into the current regulatory scheme. The article included commentary from Senior Director of ML Strategies Aaron Josephson and Mintz Associate Benjamin Zegarelli.
Bethany Hills and Benjamin Zegarelli co-author this piece reviewing the 21st Century Cures Act that requires the FDA to develop a framework for evaluating evidence in the context of drug regulation and predicting how the FDA will implement the policy.
Three attorneys from Mintz authored the initial installment of a four-part series recapping key government policies, regulations, and enforcement actions from 2016 and discussing their potential impacts on 2017.
Health Law attorney Joanne Hawana and Associate Benjamin Zegarelli authored a Law360 column on how the Senate Appropriations Committee’s approval of the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies 2017 appropriations bill sets the stage for GMO legislation. 
FDA and Health Law attorney Joanne Hawana and New York Associate Benjamin Zegarelli authored this Law360 column discussing the growing public support for genetically modified organism and genetic engineering labeling on appropriate food products across the board.
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Recognition & Awards

  • Best Lawyers in America "Ones to Watch": Administrative / Regulatory Law (2021-2022); Health Care Law (2021-2022)
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Benjamin M. Zegarelli

Of Counsel

New York