Elizabeth Orr
Managing Editor, Policy & Regulation
Elizabeth leads a small 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 Pharma Intelligence in 2015. She lives in Arlington, VA, with her husband and children.
Latest From Elizabeth Orr
Minute Insight: Thermo Fisher Gets FDA OK On Cancer Companion Diagnostic
The US FDA has approved additional indications for Thermo Fisher Scientific’s Oncomine Dx Target, allowing the companion diagnostic to be used to detect more varieties of lung and thyroid cancer.
Deal Reached On FDA User Fee Renewal
Committee leaders in the US Congress have agreed on a stripped-down path to user fee reauthorization, which will not include FDA oversight of diagnostic tests.
OIG: FDA’s EUA Approach Allowed Bad Tests To Reach Market
A review by a government watchdog found the FDA’s review process for COVID-19 diagnostics was plagued by issues including allowing low-quality tests to slip through, high reviewer workloads, and manufacturer frustration.
US FDA Finalizes Medical Device Electronic Submissions Guidance
The guidance document explains the history of and requirements for electronic submissions of 510(k)s.
FDA Finalizes Electronic Submissions Guidance
The guidance document explains the history of and requirements for electronic submissions of 510(k)s.
Teamwork: FDA And NIH Join Forces To Fund Neurodegenerative Disease Research, Medical Device Development Tools
The two federal agencies are working together to research rare conditions and fund grants for small businesses creating medical device development tools.