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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

FDA Wants To Put Hep C Tests On 510(k) Pathway

The US FDA has proposed moving two categories of hepatitis C diagnostics to class II from class III because they pose relatively low risk.

Regulation Review Pathway

FDA OK’s Insomnia Treatment Through Software Pre-Cert Program

Pear Therapeutics’ Somryst insomnia treatment tool has become the first FDA-cleared product that was reviewed through the agency’s Software Precertification Pilot Program.

Commercial Regulation

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
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