Elizabeth leads a team of Medtech Insight reporters devoted to covering medical device and diagnostics regulation in the US and abroad. As a reporter, she focuses on FDA regulation, legislation, and legal issues. A graduate of the University of Maryland College Park, she worked for outlets including FDA News, DecisionHealth (formerly UCG) and the Washington Examiner before joining Medtech Insight in 2015. She lives in Arlington, VA, with her husband and children.
Latest from Elizabeth Orr
Data recently published in The BMJ found that almost 30% of device adverse event reports filed with the US FDA are late or missing accurate date information. A relatively small number of companies account for more than half of the late reports.
The US FDA is seeing more staff turnover this week, with CDRH deputy director for science Douglas Kelly announcing his departure while the agency gets a new chief counsel and chief of staff.
A planned merger between medical device coating manufacturers Surmodics and Biocoat is facing an antitrust lawsuit from the US Federal Trade Commission. The FTC believes the move would create an illegal monopoly.
The FDA commissioner nominee offered few details on device policy, but said he was open to funding device postmarket surveillance through user fees. He also offered some defense of staff cuts while saying he would perform his own assessment before planning any more.
The US FDA has announced seven device safety actions in recent days. The most serious, which relates to a manufacturing defect in Boston Scientific’s Accolade pacemaker, has been linked to 832 injuries and two deaths.
The Voluntary Early Retirement Authority (VERA) plan would make many FDA employees with 20 or more years of service eligible for retirement, potentially increasing senior staff departures as the agency develops more layoff plans.