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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.
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Latest From Elizabeth Orr

'Intended-Use' Rule Delayed Indefinitely By US FDA

A controversial change that could have broadened the definition of "intended use" to include almost anything discussed in manufacturer communications has been delayed indefinitely as FDA reopens the comment period.

Medical Device Policy

BD Handed US FDA Warning Letter In Lead-Test Investigation

The agency letter cites quality systems, Medical Device Reporting and device clearance concerns. It stems from an ongoing investigation into lead tests distributed by Magellan Biosciences that sometimes give faulty results.

Quality Control Regulation

Medtech And US DoJ: EpiPen, Dermagraft Lead 2017 Payouts To Feds

US DoJ collected more than $1bn in penalties from device manufacturers this year, chiefly on false claims and manufacturing violations. Here is a roundup and sortable table of the payouts.

Medical Device Legal Issues

Former ArthroCare CFO Gets 50 Months In Prison

Michael Gluk, who participated in a scheme to falsely inflate ArthroCare’s earnings by parking unsold merchandise with distributors, pleaded guilty to one count of conspiracy to commit wire and securities fraud after his initial conviction was overturned.

Medical Device Orthopedics

Sterilmed Recalls Reprocessed Heart Catheter Sheath

Improper reprocessing may pose a risk of air embolism due to a leaky valve, FDA said in the recall announcement.

Medical Device Cardiology

Baxter Faces Pollution Suit

Baxter International has been sued by state and county governments in Illinois over allegations that the company dumped wastewater containing more than the legal limit of contaminants into a local lake. The firm says remediation efforts are underway.

Medical Device Legal Issues
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