The U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) has issued three new draft guidances as part of an effort to modernize its 510(k) Program for new products that can be found...more
Hogan Lovells partners Kelliann H. Payne and John J. Smith, M.D., J.D. recently joined Richard Frank, MD, PhD, Chief Medical Officer, Siemens Healthineers, and other industry leaders in person and virtually at the Health Care...more
The U.S. Food and Drug Administration (FDA) issued updated draft guidance, “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions,” which aims to help industry take a more...more