Gail H. Javitt

Gail H. Javitt counsels medical device, diagnostics, pharmaceutical, biological product, and human cellular and tissue-based product (HCT/P) companies on Food and Drug Administration (FDA) regulatory requirements across the full product life cycle. She works with manufacturers, clinical laboratories, academic medical centers, contract research organizations and institutional review boards (IRBs), patient advocacy organizations, and research and development enterprises, and she has handled disputes with the agency at both the premarket and postmarket stages. Gail also advises clinical laboratories on FDA and Clinical Laboratory Improvement Amendments (CLIA) requirements applicable to laboratory developed tests, an area she has followed closely through FDA’s shifting regulatory approach.

On the product development side, Gail provides premarket strategy for companies bringing new medical technologies to market, including premarket authorization pathways and the regulatory consequences of postmarket product modifications. She counsels sponsors and investigators on clinical trial and good clinical practice compliance, IRB engagement, and investigational device exemption (IDE) and investigational new drug (IND) requirements. She also prepares communications to FDA, including requests for designation, Citizen Petitions, and comments on proposed regulations and guidance documents, and represents clients in meetings and negotiations with the agency.

Gail’s postmarket work includes compliance counseling on medical device reporting and corrections and removals, along with responses to Form 483 inspectional observations, Warning Letters, and Untitled Letters. She also supports diligence and transactional matters in which FDA regulatory status, manufacturing, and quality systems bear on deal risk.