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Latest From Elizabeth Orr
US FDA device center's new Patient Engagement Advisory Committee held its second meeting on Nov. 15, focusing on the potential for social media and other patient-generated information to be a source of post-market medical device data.
Beth Weinman, a former enforcement lawyer in US FDA’s Office of Chief Counsel, recently joined the life sciences and FDA regulatory practice at Ropes & Gray. She spoke with Medtech Insight about whistleblower suits and FDA enforcement priorities.
US FDA officials clarified how devices can qualify for an ongoing special 510(k) pilot program during a Nov. 8 online seminar.
Stryker and plaintiff attorneys are hashing out an agreement to settle thousands of lawsuits brought by patients who say they were injured by the device-maker's hip implants.
FDA’s latest update to Unique Device Identification compliance deadlines says the agency won’t enforce direct marking UDI rules for some existing devices if the UDI can be determined in other ways.
US FDA posted online 11 medical device-related close-out letters in October. The letters bear dates going back to June 2018.