Hogan & Hartson's medical device clients range in size from small startups to established Fortune 500 companies, and include domestic and international developers, manufacturers, researchers, investors, and trade associations. Whatever our clients' size, we listen carefully and leverage our years of experience to assist them in meeting their objectives. Our experienced medical device lawyers — most with scientific backgrounds — are bolstered by regulatory science professionals who help us provide cost-effective scientific and regulatory affairs advice. The firm represents well over 500 medical device companies before the U.S. Food and Drug Administration (FDA).

Our clients rely on us for help obtaining the FDA's clearance and approval to market products, complying with the FDA's post-market requirements, and defending themselves against FDA enforcement actions. We also frequently assist with FDA-related aspects of contracts, mergers and acquisitions, and financings.

When advantageous for our clients, we call upon counsel in our pharmaceutical and biotechnology, health, white-collar criminal litigation, and legislative practices. We also provide advice and counsel on EU regulations and other countries’ requirements in the medical device area.

Former Leadership Positions

• Howard Holstein, Associate Chief Counsel at the FDA and Vice President and General Counsel of the Health Industry Manufacturers Association (now called AdvaMed)
• Marc Bozeman, Director of the Office of Compliance for the Bureau of Biologics (now the Center for Biologics Evaluation and Research) and FDA Deputy Chief Counsel for Administration
• David Fox, Associate Chief Counsel for Drugs at the FDA
• Stephen Lawrence, Compliance Officer and Investigator for the FDA and Medical Device Regulatory Counsel for a Fortune 50 pharmaceutical and devices manufacturer
• Linda Horton, Adviser to the FDA’s Acting Deputy Commissioner and FDA Director of International Policy, Deputy Chief Counsel for Regulations and Hearings, Associate Chief Counsel for Medical Devices, and Chief of the FDA’s Legislative Branch
• Joe Levitt, Director, Center for Food Safety and Applied Nutrition, FDA, and Deputy Director for Regulations and Policy at the FDA's Center for Devices and Radiological Health as well as Executive Assistant to the FDA Commissioner and other senior positions in the Commissioner's office
• John Smith, Associate Professor at Massachusetts General Hospital/Harvard Medical School, Director of Regulatory Affairs at the Center for Integration of Medicine and Innovative Technology (CIMIT), Co-director of the Massachusetts General Hospital Center for Biomarkers in Imaging, and consultant to the Radiological Devices Panel of the Medical Devices Advisory Committee at FDA’s Center for Devices and Radiological Health
• Gerry Prud'homme, member of the research faculty at the University of Maryland School of Medicine and biostatistician
• Steve Datlof, member of the clinical faculty at Temple University School of Medicine