Overview
Our team advises global manufacturers, mid-size companies, and start-ups across the MedTech spectrum, including traditional devices, diagnostics, digital health, Software as a Medical Device (SaMD), artificial intelligence/machine learning (AI/ML)-enabled technologies, and combination products. We provide end‑to‑end regulatory support, including product classification and pre‑submission strategy; clinical study design and execution; product clearance and approval; labeling, advertising, and promotion; quality system transitions and compliance (including FDA’s QMSR/ISO 13485 alignment); supplier controls and manufacturing; product safety, post-market surveillance and vigilance reporting; inspections, warning letters, and enforcement responses; recalls and field actions; and complex litigation and dispute resolution. Our clients benefit from our firm’s capabilities in related areas such as device transactions, research funding, reimbursement and health care regulation, privacy and cybersecurity, and government investigations.
Digital Health & AI Technologies: We have significant experience advising digital health companies and healthcare institutions with respect to their digital health and AI offerings that could trigger scrutiny by the FDA and other regulatory authorities. We have advised on myriad considerations, including regulatory classification of SaMD by the FDA, AI/ML-based software regulation, real-world evidence/real-world data (RWE/RWD) regulation, device clearance and approval, cybersecurity requirements, and more.
Experience
Representative matters include:
- Guiding medical device companies through product development, including advising on device classification, selecting the appropriate premarket pathway (PMA, 510(k) or De Novo), preparing and supporting IDE applications for clinical investigations, and counseling on design control requirements.
- Advising multinational medical device manufacturers on FDA marketing authorization submissions, whether FDA premarket review is required for planned changes to products, device safety and labeling issues, and product advertising and promotional strategies.
- Advising medical device manufacturers across a range of product types on Quality Management System Regulation (QMSR) issues, Medical Device Reporting, Correction and Removal Reports, and product recalls. Among other things, we have helped clients develop action plans and prepare written responses to FDA inspectional observations and Warning Letters, negotiate with FDA regarding remedial actions, and implement and obtain FDA close-out of product recalls.
- Advising medical device manufacturers on import and export issues.
- Representing medical device manufacturers in responding to subpoenas from the Department of Health and Human Services (HHS) Office of Inspector General relating to the quality and performance issues of certain products.
- Counseling on regulatory considerations applicable to the development and marketing of AI/ML-based tools, including requirements for algorithm training and validation, applicable marketing pathways, and the FDA’s evolving approach to regulation of AI/ML technologies.
- Assessing whether digital health products may be subject to FDA regulation as medical devices, developing guardrails to help ensure that company practices do not inadvertently trigger FDA obligations, and advising on regulatory strategy and compliance for new market entrants as well as established medical products manufacturers.
- Advising on the FDA regulatory implications of companion mobile applications developed for use with prescription drugs, including whether such applications would be considered FDA-regulated medical devices or incorporated into prescription drug labeling and the associated regulatory requirements.
