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.