Elizabeth Orr
Managing Editor, Policy & Regulation
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
Proposed Rule Would Apply FDA’s Diagnostic Rules To LDTs
A proposed rule from the US Food and Drug Administration would allow the agency to take on regulation of lab-developed tests by phasing out the previous approach of enforcement discretion
OMB Clears Proposed Rule On Lab-Developed Tests
The US FDA appears poised to release long-promised regulations on lab-developed tests. However, some industry observers still have doubts as to whether the agency is truly prepared.
‘The Power Of Persuasion’: FDA Ombudsman Discusses Her Role
During a recent webinar, 20-year FDA chief ombudsman Laurie Lenkel explained why her office sees so many device-related cases and what and ombudsman can, and cannot, do for industry.
FDA’s International Harmonization Plan Points To Ongoing Priorities
A new draft global harmonization plan from the device center at the US Food and Drug Administration may not contain any surprises, but it does highlight increasing agency engagement with international bodies.
Contingency Planning: Guidance Doc Details Handling Clinical Trials During Emergencies
The agency urges sponsors to keep patient safety “first and foremost” in determining how to continue a clinical trial during a natural disaster, public health emergency, or other crisis.
News We're Watching: Studies Back Nevro Pain Treatment, FTC Blesses Resonetics Nitinol Deal, Genetic Test Identifies Best RDN Patients
This week, studies supported Nevro’s spinal cord stimulation therapy and a VRx system that helps reduce pain; the American Medical Association found inconsistent insurance coverage of digital therapeutics; and Geneticure announced a cheek-swab test to identify which patients are most likely to benefit from renal denervation.