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.
viewpoints
Regional Challenges in Regulating Medical Product AI
October 30, 2024 | Webinar | By Benjamin Zegarelli
In this webinar we discuss the regional challenges in regulating medical product AI with a focus on different regulatory approaches in the US, EU, and UK.
OHRP Workshop Highlights Artificial Intelligence Uses, Concerns in Human Research
October 9, 2024 | Blog | By Benjamin Zegarelli, Pat Ouellette
The Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) recently held its 2024 Exploratory Workshop titled “The Evolving Landscape of Human Research with AI – Putting Ethics to Practice” (the Workshop). Although the individual presentations and panel discussions throughout the Workshop covered a range of topics and raised a number of interesting questions and hypotheticals, the panelists did not draw any specific conclusions or reach any kind of consensus about next steps to address the critical issues. Even so, the panelists provided some crucial insights that companies and regulators must grapple with in the context of expanding use cases for AI in human research and creating rules governing such uses.
FDA Continues to Intentionally Incorporate AI into Medical Product Development with Its Establishment of a New Internal Advisory Body
September 4, 2024 | Blog | By Joanne Hawana, Benjamin Zegarelli
Agencies across the federal government continue to grapple with how to respond to the directives in President Biden’s October 2023 executive order on artificial intelligence, including the Food and Drug Administration (FDA) and its parent agency the Department of Health and Human Services (DHHS). As summarized in this handy Mintz/ML Strategies timeline of the actions set forth in President Biden’s AI executive order, DHHS has a mandate to “develop a strategy for regulating the use of AI in the drug development process” and a deadline of October 29, 2024 to meet that obligation. Notably, earlier this year DHHS announced a functional reorganization within the department that included creating the position of Chief AI Officer in response to the presidential order.
CMS Issues Final Notice on Program for Breakthrough Device Reimbursement but Industry Looks to Congress for More Inclusive Solution
August 19, 2024 | Blog | By Benjamin Zegarelli, Joanne Hawana, Anthony DeMaio, Pamela Mejia
Obtaining Medicare coverage and reimbursement for medical devices is notoriously more difficult than for drugs or biologics, and any progress on expanding coverage pathways has been agonizingly slow for industry stakeholders. An announcement on August 7, 2024 by the Centers for Medicare and Medicaid Services (CMS) of a final notice for the Transitional Coverage for Emerging Technologies (TCET) pathway was therefore a welcome development. However, digging under the surface of the TCET pathway uncovers some less than thrilling details. CMS’s failure to address stakeholder proposals to modify the TCET program has increased interest and advocacy around Congress’s consideration of the Ensuring Patient Access to Critical Breakthrough Products Act. We explore both the shortcomings of the TCET pathway and the possible legislative solutions to its perceived gaps below.
FDA and CTTI Hold Joint Workshop on AI in Drug Development – AI: The Washington Report
August 9, 2024 | Article | By Benjamin Zegarelli, Joanne Hawana, Matthew Tikhonovsky
Read about the Food and Drug Administration (FDA) and the Clinical Trials Transformation Initiative (CTTI) joint workshop in the latest edition of AI: The Washington Report, a joint undertaking of Mintz and ML Strategies covering potential federal legislative, executive, and regulatory activities related to AI.
Five Observations from FDA’s Responses to Comments in the Final Rule on LDTs
July 10, 2024 | Blog | By Benjamin Zegarelli
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.
FDA’s Final LDT Rule Is Here, and the Changes Show the Agency Is Serious and Actually Listening to Stakeholders
May 6, 2024 | Blog | By Joanne Hawana, Benjamin Zegarelli
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).
Navigating Health Tech: Regulations for AI/ML in Medical Devices and Software
April 16, 2024 | Video | By Benjamin Zegarelli, Pat Ouellette
FDA Warning Letter Is a Stark Reminder That If You Claim Your Product Is RUO, It Has to Be RUO
April 3, 2024 | Blog | By Joanne Hawana, Benjamin Zegarelli
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.
FDA Needs a New Approach to AI/ML-Enabled Medical Devices
March 12, 2024 | Blog | By Benjamin Zegarelli
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.
News & Press
The Best Lawyers in America 2025 Recognizes 184 Mintz Attorneys across 56 Practice Areas
August 15, 2024
187 Mintz attorneys have been recognized by Best Lawyers® in the 2025 edition of The Best Lawyers in America©. Notably, three Mintz attorneys received 2025 “Lawyer of the Year” awards, and 64 firm attorneys were included in the 2025 edition of Best Lawyers: Ones to Watch.
ACLA Sues FDA To Block New LDT Oversight
June 3, 2024
LDT Oversight Gets Long-Awaited FDA Final Rule
April 30, 2024
What You Need to Know About FDA's Proposed Regulation of LDTs
January 26, 2024
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.
Digging Into The Debate On FDA's Proposed Lab Test Rule
January 3, 2024
Exploring FDA's Stance on LDTs and AI
December 12, 2023
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.
FDA Guidelines Put Focus on Medical Cybersecurity
October 24, 2023
Of Counsel Benjamin Zegarelli was quoted in a Business Insurance article discussing the impact of new FDA guidelines focused on medical cybersecurity.
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©.
FDA Weighs When Software Becomes A Medical Device
May 26, 2023
Axios interviewed Of Counsel Benjamin Zegarelli about the citizen petition that was filed with the FDA to recall Bamboo's NarxCare.
Mintz Advises Underwriters of Viking’s $287.5 Million Public Offering of Common Stock
April 10, 2023
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.
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
Exploring FDA’s Expedited Programs: Applicability and Eligibility
ACI’s 41st FDA Boot Camp
Boston, MA
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 (2021-2025)