Scott Danzis is a partner in the firm’s Food & Drug and Health Care practice groups. His practice focuses primarily on the regulation of medical devices, but also includes regulation of drugs, biologics, and tobacco products. Mr. Danzis regularly works with companies in developing strategies for interacting with the U.S. Food and Drug Administration (FDA), including strategies for clinical development and premarket review (including appeals and dispute resolution, when needed). He also advises on compliance with postmarket requirements, including advertising and promotion restrictions, quality system and manufacturing requirements, postmarket reporting, recalls, and enforcement actions.
From 2006 to 2008, Mr. Danzis served as the Special Assistant to the Chief Counsel of the U.S. Food and Drug Administration. While at FDA, he was broadly involved in a wide range of legal and regulatory matters related to medical devices and drugs. He also worked on implementing key provisions of the Food and Drug Administration Amendments Act of 2007.
Mr. Danzis has significant experience in the following areas:
- FDA regulatory strategies, including strategies for the premarket review (510(k)s, PMAs) of medical devices;
- Appeals and dispute resolution within FDA;
- IDEs, INDs, and clinical trial regulation;
- Advertising, promotion, and scientific exchange, including responding to enforcement actions and investigations;
- Imports and exports of FDA regulated products;
- QSR and cGMP requirements, including responding to FDA 483s and enforcement actions;
- Product recalls;
- Adverse event and MDR reporting;
- FDA consent decrees and OIG corporate integrity agreements;
- Regulatory due diligence;
- Compliance with antifraud statutes, including the anti-kickback statute and the False Claims Act.
Mr. Danzis recently developed and edited a book on the regulation of in vitro diagnostic products and laboratory testing, In Vitro Diagnostics: The Complete Regulatory Guide (FDLI, 2010). He currently serves as an Adjunct Professor at the Georgetown University Law Center where he teaches a course on the regulation of drugs, biologics, and medical devices.
Mr. Danzis clerked for the Honorable Chester J. Straub on the U.S. Court of Appeals for the Second Circuit. He is a graduate of the University of Virginia School of Law where he was the Editor-in-Chief of the Virginia Law Review and elected to the Order of the Coif. He holds a Masters Degree from George Washington University in Health Care Management and Policy, and a Bachelor of Science from Cornell University.