Ryan Foringer

Regulatory affairs consultant providing FDA strategy for moderate- and high-risk medical devices, including AI-enabled technologies, across multiple clinical specialties. Advise clients on regulatory pathways — 510(k), De Novo, and PMA — where complexity, novelty, or lack of precedent requires tailored engagement strategies. Serve as the FDA interface for clients, guiding pre-submission planning, meeting strategy, and risk positioning to advance both regulatory and business goals. Leverage a former FDA Reviewer background and engineering training to anticipate Agency concerns and reduce downstream regulatory risk.

Regulatory affairs leader with experience spanning neurological, cardiovascular, and diabetes medical device programs in both growth-stage and established environments. Led cross-functional teams in the development of FDA regulatory strategies across the full product lifecycle, including Pre-Submissions, Breakthrough Device Designation, De Novo, IDE, and modular PMA submissions. Advised international affiliates on U.S. FDA compliance across quality systems (21 CFR 820, ISO 13485), MDR reporting, labeling and promotion, and manufacturing changes. Partnered with clinical and development teams to design FDA-facing clinical programs through Pre-Submission and IDE pathways to support future marketing applications.

*Built complementary experience in FDA compliance, enforcement, and inspection‑based decision‑making.* Served as Compliance Officer in the Division of Enforcement, Dietary Supplement and Labeling Assessment Branch. Assessed evidentiary adequacy of domestic and foreign inspection reports, import cases, and website claims to support enforcement actions or alternative compliance pathways. Led enforcement case reviews and coordinated with Center experts on GMP, labeling, and health claims violations. Applied inspection and enforcement frameworks that parallel medical device compliance models, strengthening regulatory risk assessment perspective.

*Primary FDA experience most directly aligned with current medical device regulatory focus.* Served as pre‑market chemical engineering reviewer and Lead Reviewer for gastroenterology medical devices within CDRH. Led FDA review teams as project manager for 510(k)s, PMAs, PMA supplements, IDEs, and manufacturing change submissions across pre‑ and post‑market pathways. Directed FDA Pre‑Submission reviews, developed the Agency’s formal written feedback, and chaired sponsor meetings (teleconference and in‑person). Evaluated manufacturing change data, including IQ/OQ/PQ, to determine regulatory impact and adequacy. Synthesized cross‑disciplinary input from FDA subject‑matter experts to support safety and effectiveness determinations. Authored FDA decision memoranda documenting the regulatory rationale for approval or disapproval outcomes.