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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

COVID-19 Leads FDA To Relax Rules On Surgical Masks, Offer EUAs For Reprocessing Some Respirators

The US agency is relaxing some regulatory requirements on facial masks and actively pursuing ways to reprocess N95 respirators used by medical staff under an immediately-in-effect guidance document.

United States Quality Control

When Chasing COVID-19 Market Opportunities, Watch For Regulatory Hurdles

Companies offering OTC sample collection kits to help diagnose COVID-19 quickly fell under scrutiny in the US because the FDA hasn’t authorized any OTC tests.

In Vitro Diagnostics Regulation

COVID-19: FDA Device Center Chops In-Person Meetings, Lengthens Submission Deadlines

The US agency’s device center has offered an extension on some submission deadlines and announced a transition to teleconferences from in-person meetings during the COVID-19 pandemic.

Regulation FDA

Cepheid Nabs First FDA Authorization For Rapid-Response COVID-19 Test

A rapid-response test from Danaher business unit Cepheid will be the first quick COVID-19 diagnostic to reach the US market, the US FDA announced on 21 March.

Coronavirus COVID-19 FDA

FDA Lets Some Changes To Monitoring Tools Bypass Clearance Process During COVID-19 Pandemic

Manufacturers can expand the remote-use capabilities of patient-monitoring devices like thermometers and stethoscopes without alerting the US FDA during the coronavirus crisis, a new guidance document from the agency says.

Coronavirus COVID-19 FDA

UK Court Blocks Edwards’ TAVR Device For Patent Infringement

Edwards’ Pascal transcatheter valve repair devices has been blocked from most use after being found to infringe on Abbott’s patents by a British court.

United Kingdom Commercial
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