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Benjamin M. Zegarelli

Of Counsel

[email protected]

+1.212.692.6261

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Benjamin provides regulatory compliance counsel to global clients developing and marketing FDA-regulated products with the goal of mitigating compliance concerns and obstacles facing product candidates or commercialized products while helping clients achieve commercial success. With a clear focus on medical device compliance matters, Benjamin advises life science and health care industry clients, on the federal and state laws governing the design, production, quality, and commercialization of a breadth of devices, including traditional hardware devices, in vitro diagnostics, and software as a medical device (“SaMD”). He has extensive experience guiding medical device companies through the FDA regulatory process to identify the optimal marketing authorization pathway, assisting with FDA communications and requests, ensuring that submissions to FDA meet regulatory requirements, and helping to establish robust post-market quality systems and compliance controls.

In particular, Benjamin has counseled numerous SaMD developers and software as a service (SaaS) companies, especially those designing software that incorporates artificial intelligence (AI) or machine learning (ML) functionalities, on FDA regulatory strategy, including preparing for pre-submission meetings with FDA, submitting applications for marketing authorization, and responding to agency requests for additional information. He also regularly advises clinical laboratory clients on navigating regulations governing in vitro diagnostic tests, and specifically, the development, distribution, and marketing of laboratory developed tests and home-use specimen collection kits. In addition, Benjamin assists life sciences clients with medical product distribution, advertising, promotion, and labeling compliance, as well as 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 take strategic actions in navigating the communications process with FDA and implementing appropriate corrective actions to address compliance issues.

In his practice, Benjamin coordinates and performs diligence reviews as part of corporate transactions and securities offerings involving life science and health care companies. He is well versed in the process of developing policy positions for life sciences clients and advocating such positions before FDA and other governmental bodies through written comments and in-person meetings. His practice also includes representing both clinical trial sponsors and clinical sites on regulatory issues in clinical research studies, including compliance with government grant regulations, as well as drafting and negotiating the agreements necessary to perform clinical trials.

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 “Digital Health in the Metaverse: Navigating the Interplay Between Healthcare Delivery and Healthcare Laws” and “Clarifying the Clinical Trials Process for Drugs and Biologics.” He has a Master of Science degree in organic chemistry, and he previously worked as a research chemist in the discovery group of a major research-based pharmaceutical company.

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 numerous Mintz clients developing SaMD or other digital health technologies on selecting the most appropriate regulatory strategy for their products in light of contemporary FDA policies and guidance and avoiding potential regulatory pitfalls relating to software design, quality controls, and pre-market submissions.
  • Counseled multiple Mintz clinical laboratory clients on the regulatory framework governing in vitro diagnostic tests and restrictions on the development, distribution, and commercialization of laboratory developed tests (“LDTs”) and home-use specimen collections kits.
  • Assisted a clinical laboratory with responding to multiple regulatory inquiries from FDA and developing a comprehensive corrective action plan addressing noncompliance allegations relating to home-use specimen collection kits and diagnostic assays.
  • Participates in the Medical, Legal, and Regulatory (“MLR”) Committees that are engaged in promotional review activities on behalf of multiple clients with recently approved new drugs and biologics.
  • 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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Now that the final rule on laboratory developed tests (LDTs) has been available for over a month and the stages of the enforcement discretion phaseout process and the Food and Drug Administration’s (FDA’s) newly proposed policies for continuing limited enforcement discretion for certain types of LDTs have been thoroughly described and dissected (including by us in our previous post), it’s high time to dig into FDA’s perspectives on the comments it received on the proposed rule. 

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The Food and Drug Administration (FDA) published its final rule on laboratory developed tests (LDTs) in the Federal Register on May 6, marking a watershed moment in the agency’s arduous decade-plus-long journey toward winding down its historical enforcement discretion posture for LDTs. But FDA’s crusade is far from over. It will have much to do to implement the four-year phase-out period described in the final rule and those efforts may be delayed by litigation seeking to enjoin implementation of the rule altogether. While we wait for the litigation shoe to drop, let’s take a look at what the final rule says and the changes FDA made in these highly significant policy decisions since the Notice of Proposed Rulemaking was published on October 3, 2023 (see our previous posts on the NPRM here and here).

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In vitro diagnostics, or IVDs, have a somewhat unique position among the gamut of products that the Food and Drug Administration (FDA) oversees and regulates on behalf of the U.S. public. IVDs are classified as medical devices and include “reagents, instruments, and systems intended for use in diagnosis, including determining the state of health, through the collection, preparation, and examination of specimens taken from the human body.” Unlike human drug and non-IVD device products, which generally must be authorized for a specific medical use prior to commercialization, IVD products may be sold for certain scientific research studies without FDA authorization, but such IVD products may not be sold for clinical diagnostic use. 

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We have been writing about software as a medical device (SaMD) for years, tracking the Food and Drug Administration's (FDA) efforts to keep up with the fast-paced development of digital technology, such as launching the Digital Health Center of Excellence, implementing predetermined change control plans, and issuing various digital health guidances on device software functions, clinical decision support software, cybersecurity, and other topics. In anticipation of FDA’s Artificial Intelligence /Machine Learning (AI/ML) Medical Devices Workshop in October 2021, we posted a brief history of the agency’s regulatory oversight of software through the traditional medical device regulatory framework established in the 1970s, in which we highlighted the numerous challenges associated with such an approach. But now, with the rise of artificial intelligence and machine learning and the proliferation of AI/ML-enabled software throughout the health care industry, FDA is facing enormous challenges using an outdated, procrustean regulatory framework to maintain standards of safety and quality for such software devices. It is becoming increasingly clear that innovation in the AI/ML and digital health technology space is advancing rapidly, as FDA Commissioner Rob Califf has emphasized in many recent public appearances, and that the traditional device framework is quickly becoming unworkable for such technologies.

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In this episode of Health Law Diagnosed, host Bridgette Keller is joined by Mintz Health Law attorneys Joanne Hawana and Benjamin Zegarelli to discuss the FDA’s long-awaited proposed rules that actively regulate laboratory developed tests (LDTs).

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After a long wait, the U.S. Food and Drug Administration (FDA) recently published a Final Rule to harmonize the Quality System Regulation (QSR) codified at 21 C.F.R. Part 820 with the internationally accepted standard for medical device quality management systems established by the International Organization for Standardization, the 2016 edition of ISO 13485, “Medical devices - Quality management systems - Requirements for regulatory purposes” (known as “ISO 13485:2016”). We previously mentioned back in January 2021 that FDA had plans to initiate notice-and-comment rulemaking to describe the harmonization process sometime in 2021, plans that the agency had been discussing for years prior. FDA finally published a Notice of Proposed Rulemaking for the harmonization in February 2022 and, then, following the agency’s consideration of stakeholders’ submitted comments, it issued the Final Rule on February 2, 2024.

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In 2023, the FDA navigated challenges while achieving significant public health milestones. Member Joanne Hawana and Of Counsel Benjamin Zegarelli highlight key takeaways from the year, addressing multifaceted issues such as CBD regulation, the overhaul of in vitro clinical tests, and the management of manufacturing failures. These pivotal topics underscore the FDA’s proactive approach to evolving healthcare regulations and technological advancements. 

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The U.S. Food and Drug Administration (FDA) recently released a proposed rule that would seek to regulate laboratory developed tests (LDTs) as medical devices under the Federal Food, Drug, and Cosmetic Act (FDCA). This rule could reshape the landscape of LDTs and, as expected, has generated substantial attention and feedback from the public, with both supportive and negative comments flooding in. We previously provided a summary of the proposed rule and FDA’s lengthy justification for it here. In this blog post, we will examine some of the key arguments presented in the public comments submitted to Docket FDA-2023-N-2177, as well as public statements published by industry trade associations.

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A new battle is emerging in the fight for health equity, and it’s centered on the humble pulse oximeter. On November 1, 2023, 25 state attorneys general sent a letter to the Food and Drug Administration (FDA) demanding that the agency take urgent action to address pulse oximeter inaccuracies that continue to create health care risks for people of color. The letter comes exactly one year after a public meeting held by the Anesthesiology and Respiratory Therapy Devices Panel of the FDA’s Medical Devices Advisory Committee titled “Pulse Oximeter Accuracy and Limitations,” and nearly 21 months after the agency issued a safety communication about pulse oximeter inaccuracies when used on people with dark skin pigmentation (see our previous blog post on pulse oximeter performance here).

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News & Press

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MDDI interviewed Of Counsel Benjamin Zegarelli on the controversy surrounding the FDA’s proposed regulation to oversee laboratory-developed tests (LDT) and his thoughts on the future of LDTs.

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Of Counsel Benjamin Zegarelli appeared on MDDI’s Let’s Talk Medtech Podcast. Ben provides some important regulatory updates surrounding laboratory-developed tests, artificial intelligence, and software.

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Of Counsel Benjamin Zegarelli was quoted in a Business Insurance article discussing the impact of new FDA guidelines focused on medical cybersecurity.

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Mintz is pleased to announce that 120 firm attorneys have been recognized as leaders by Best Lawyers® in the 2024 edition of The Best Lawyers in America©.

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Axios interviewed Of Counsel Benjamin Zegarelli  about the citizen petition that was filed with the FDA to recall Bamboo's NarxCare.

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NEW YORK – Mintz represented the syndicate of underwriters led by William Blair & Company, L.L.C., in the public offering of 17,242,000 shares of common stock of Viking Therapeutics, Inc. (“Viking”) (Nasdaq: VKTX), a clinical-stage biopharmaceutical company focused on the development of novel therapies for metabolic and endocrine disorders, at an initial offering price of $14.50 per share.

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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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Events & Speaking

Speaker
Sep
20
2023
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Mar
22
2023

Clarifying the Clinical Trials Process for Drugs and Biologics

ACI's 40th FDA Boot Camp

Virtual Conference

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Panelist
Dec
13
2022

IP Considerations for Medical Device Companies

Boston Bar Association

Online Event

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Speaker
Nov
10
2022

Regulation of Over-the-Counter (OTC) Drugs

Food and Drug Law Institute

Online Event

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Speaker
Jan
26
2022
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Aug
19
2021

Law Over Lunch

Food and Drug Law Institute

Online Event

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Apr
21
2020
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Apr
14
2020

FDA in the Time of COVID-19

View the Webinar Recording

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Speaker
Apr
24
2019

16th Annual Medical Device Quality Congress

Servicing & Remanufacturing

Bethesda, MD

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Mar
26
2019

Mount Sinai Innovation Partners Lecture

Protecting and Commercializing Your Innovation – FDA Regulation

New York, NY

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Recognition & Awards

  • Best Lawyers in America "Ones to Watch": Administrative / Regulatory Law (2021-2022); Health Care Law (2021-2024)

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