Medtech Insight is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Elizabeth Orr

Washington, DC
Elizabeth Orr focuses on legal affairs affecting the medical device industry. Before joining Informa in September 2015, she spent three years spent reporting on all things device-related at FDANews. She remains fascinated by the ever-changing master class on technology, government regulations, advances in health care and more that is covering the device industry. Elizabeth’s past employers include DecisionHealth (formerly UCG); the Society of Interventional Radiology; and the Washington Examiner.  A graduate of the College of Journalism at the University of Maryland College Park, she lives in Arlington, Va., with her husband and children.
Advertisement
Set Alert for Articles By Elizabeth Orr

Latest From Elizabeth Orr

FDA Urges Caution in Some Neurovascular Stent Use

US FDA has issued new guidelines to providers because some patients experienced strokes or died after being treated for unruptured brain aneurysms with some neurovascular stents.

Medical Device Neurology

US FDA Finds Ongoing CAPA Issues In Zimmer Plant Reinspection

A follow-up inspection evaluating Zimmer Biomet’s progress in remediating issues documented in a 2016 FDA Form-483 uncovered 11 observations, eight of them repeats.

Quality Control Orthopedics

Watchdog OKs Ostomy Company Samples

An ostomy supply manufacturer can give free samples to potential clients without violating anti-kickback rules, the US Department of Health & Human Services’ Office of the Inspector General wrote in a recent advisory opinion.

United States Enforcement

DOJ Memo Could Offer Additional Defenses In Enforcement Actions

Industry should be cautious in interpreting a recent US Department of Justice memo stating DOJ wouldn’t take enforcement actions based on failure to comply with guidance documents alone, according to experts. But the document still could offer assistance to manufacturers fighting enforcement actions.

Legal Issues Enforcement

FDA Chief Counsel Addresses First Amendment, Enforcement

US FDA Chief Counsel Rebecca Wood discussed ongoing reforms to FDA’s free speech enforcement approach and other enforcement priorities at a recent conference.

Legal Issues FDA

Warning Letter Close-Outs – April 2018

US FDA released one device-related close-out letter in March.

Device Warning Letters FDA
See All
Advertisement
UsernamePublicRestriction

Register