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Elizabeth Orr
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Latest From Elizabeth Orr
FDA Wrestles With Social Media At Patient Engagement Meeting
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.
Fresh From US FDA's Chief Counsel Office, Beth Weinman Talks Qui Tam And Compliance
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.
Special 510(k) Pilot Includes All Qualifying Submissions, FDA Says
US FDA officials clarified how devices can qualify for an ongoing special 510(k) pilot program during a Nov. 8 online seminar.
Stryker To Settle Hip Implant Suits
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.
US FDA Tweaks Direct Marking Rules In UDI Enforcement Delay
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.
Warning Letter Close-Outs – October 2018
US FDA posted online 11 medical device-related close-out letters in October. The letters bear dates going back to June 2018.