Medical Device Legal News with Sam Bernstein: Episode 18
The Patient Engagement Advisory Committee to the Food and Drug Association (FDA) met recently to discuss cybersecurity in medical devices. Medical devices are increasingly connected to the internet, hospital networks, and...more
The U.S. Food and Drug Administration (FDA) issued on July 27, 2016, a draft guidance document addressing how it may use data and evidence collected outside of the traditional clinical trial context to support medical device...more
In this edition of our Privacy & Cybersecurity Update, we discuss the revised Privacy Shield and what companies should be doing to prepare for the new program, the FTC's reinstatement of its LabMD case, the European...more
The Los Angeles Times reports that in recent years, several devices, including certain reusable medical scopes, metal-on-metal hip replacements, transvaginal meshes, and lead wires in heart defibrillators have been recalled. ...more