Gail Javitt provides strategic regulatory advice for leading medical device, pharmaceutical, biological products and dietary supplement companies throughout the product lifecycle. She has successfully resolved disputes at both the pre- and post-market stage.

She advises clients interested in bringing innovative medical technologies to market, including those in the diagnostic, software and aesthetic medicine sectors, tackling challenging questions related to appropriate pathways to market for novel products. Areas of expertise include product classification, including the request for designation process, clinical trial (GCP) compliance, investigational device exemptions (IDE), the 510(k) and PMA review pathways, regulatory implications of modifications to 510(k) devices, medical device reporting, corrections and removals, companion diagnostics and laboratory developed tests.

Gail has published and spoken widely on issues at the intersection of law and science, including FDA regulation of genetic testing, precision medicine, and next generation sequencing. Previously, Gail was law and policy director at the Genetics and Public Policy Center in Washington, DC. where she was responsible for developing policy options to guide the development and use of reproductive and other genetic technologies.