Jason Ryans

Jason Ryans, Ph.D., is a senior associate in Exponent's Biomedical Engineering & Sciences practice with over 8 years of experience in FDA regulatory affairs, medical device policy, and regulatory compliance. As a former Regulatory Policy Analyst at the FDA Center for Devices and Radiological Health (CDRH), he advises medical device manufacturers, legal teams, and healthcare companies on the interpretation and application of FDA statutes, regulations, guidance documents, and policy. His expertise focuses on FDA regulatory strategy, quality systems and postmarket compliance, and medical device litigation and regulatory disputes.

FDA Regulatory Strategy

Dr. Ryans advises medical device manufacturers on FDA regulatory pathways and premarket strategies across the total product lifecycle, including 510(k), De Novo, and Premarket Approval (PMA) pathways. He evaluates device classification, intended use, technological characteristics, predicate considerations, and applicable special controls to help clients develop well-supported regulatory strategies.

Drawing on seven years of experience as a Regulatory Policy Analyst at the FDA Center for Devices and Radiological Health (CDRH) advising review staff and industry, Dr. Ryans provides practical insight into the interpretation and application of FDA statutes, regulations, guidance documents, and policy. He translates complex, evolving regulatory requirements into actionable recommendations that help clients identify potential issues, prepare for FDA interactions, and align product-development and submission strategies with current agency expectations.

Medical Device Litigation & Regulatory Dispute Support

Dr. Ryans supports law firms, manufacturers, and in-house counsel in litigation and dispute matters involving FDA-regulated medical devices. He assists legal teams in evaluating FDA regulatory issues that arise in product liability, contract dispute, false advertising, and compliance-related matters.

His analyses focus on the interpretation and application of FDA statutes, regulations, guidance documents, and regulatory policy, as well as the regulatory significance of evidence commonly encountered in litigation and disputes, including:

• Premarket Regulatory Evidence: regulatory pathway determinations; marketing submissions (510(k), De Novo, & PMA); Q-Submissions; FDA correspondence
• Postmarket Regulatory Evidence: complaints files and Medical Device Reports (MDRs); recalls, corrections, and removals; product lifecycle management activities and regulatory change assessments
• Compliance and Enforcement Evidence: quality management system documentation and records; corrective and preventative action (CAPA) activities; complaint handling and adverse event reporting processes; FDA inspection information including Form 483 observations and classification; warning letters and other enforcement actions

When called upon as an expert witness, Dr. Ryans provides independent opinions regarding FDA regulatory requirements and the interpretation of regulatory evidence relevant to the issues in dispute.

Quality Systems & Postmarket Compliance

Dr. Ryans advises medical device manufacturers on quality management system (QMS) requirements, FDA compliance risk, and postmarket compliance requirements throughout the product lifecycle. He helps organizations evaluate the effectiveness of their quality systems, identify compliance vulnerabilities, and develop strategies to address evolving FDA expectations.

His experience includes FDA's Quality Management System Regulation (QMSR), alignment with ISO 13485, CAPA systems, complaint handling, adverse event reporting under MDR regulations, and postmarket surveillance. He helps manufacturers build and maintain compliance programs that satisfy both FDA expectations and international quality standards. Dr. Ryans assists clients in understanding how FDA requirements are interpreted and applied in practice and how quality system decisions may affect regulatory, operational, and business risks.