Vident Partners provides vetted FDA regulatory expert witnesses for cases involving pharmaceutical approval disputes, medical device compliance, labeling requirements, and regulatory submission adequacy in product liability litigation. Request a referral today.
Find a FDA Regulatory Expert →Overview
FDA regulatory experts evaluate compliance with Food and Drug Administration requirements for pharmaceuticals, medical devices, biologics, and food products. They address whether manufacturers followed applicable regulatory pathways, met Current Good Manufacturing Practice (CGMP) requirements under 21 CFR Parts 210-211, submitted adequate labeling and warnings, and complied with post-market surveillance obligations 1. Medical device compliance involves either the 510(k) premarket notification pathway -- requiring demonstration of substantial equivalence to a legally marketed predicate device -- or the more rigorous Premarket Approval (PMA) process 2. As of February 2, 2026, medical device quality systems are governed by the updated Quality Management System Regulation, which incorporates ISO 13485:2016 3. These experts are essential in pharmaceutical product liability cases, medical device litigation, and regulatory enforcement proceedings where FDA compliance is a central issue 4.
All medical devices marketed in the United States must demonstrate either substantial equivalence to a predicate device through the 510(k) pathway or obtain Premarket Approval -- making regulatory pathway compliance a threshold question in device litigation.
Case Types
Pharmaceutical product liability and regulatory compliance
Medical device 510(k) and PMA compliance disputes
Drug and device labeling adequacy challenges
FDA Good Manufacturing Practice violation cases
Post-market adverse event reporting obligations
Qualifications
Related Specialties
FAQ
An FDA regulatory expert should have extensive experience in regulatory affairs, ideally at both the industry and agency level. They should hold RAC certification or equivalent, demonstrate thorough knowledge of the applicable FDA regulatory pathway, and have experience with the specific product type at issue. Former FDA reviewers and industry regulatory affairs directors are common expert backgrounds.
FDA regulatory experts are needed in pharmaceutical product liability cases, medical device litigation, drug and device labeling disputes, GMP violation and quality system regulation cases, and any litigation where the adequacy of FDA regulatory submissions or compliance with FDA requirements is at issue.
In general, regulatory expert fees are determined by the expert themselves, based on a variety of criteria. Among those criteria are professional experience, forensic experience, academic qualifications, regulatory expertise, and publications. Vident does have some influence over expert fees by comparing experts within a specialty, but ultimately it is a personal decision by the expert.
Vident Partners connects attorneys with qualified fda regulatory expert witnesses. Complimentary consultation, 24-hour turnaround, no obligation.
Request an Expert →