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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.

Latest From Elizabeth Orr

Teleflex Subsidiary Faces Federal False Claims Investigation

Urology device developer NeoTract, which Teleflex purchased in 2017, is now under scrutiny for potential FCA violations. 

Commercial Enforcement

US FDA Highlights OTC Market With Template To Boost COVID-19 Test Development

FDA template explains what information the agency wants to see in regulating COVID-19 tests to be performed outside the laboratory environment.

OTC Devices FDA

FDA Boosts Development Of OTC COVID-19 Tests With New Template

A new template from the US FDA explains what information the agency wants to see in regulating COVID-19 tests to be performed outside the laboratory environment.

Coronavirus COVID-19 FDA

Final Guidance Addresses Regulation Of Multi-Function Products

The US FDA has finalized a guidance document on regulation of products with multiple functions that include non-device uses. While inspired by software regulation, the recommendations apply to all technology.

Guidance Documents Digital Health

Guidance: FDA Acts To Improve Availability Of Viral Transport Media

The US FDA is relaxing some rules around viral transport media as part of its efforts to ensure supplies needed in the fight against COVID-19 reach US shelves.

Coronavirus COVID-19 FDA

FDA Action-Item List Shows Plans To Revamp De Novo, Combo Product, QSR Regs, And More

Planned US FDA actions on the spring 2020 Agency Rule List show expected rules around de novo applications, and combination product classification and appeals – as well as the long-awaited Quality System Regulation overhaul.

FDA Regulation
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