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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

Warning Letter Close-Outs – November 2020

The US Food and Drug Administration posted two device-related closeout letters in November.

Device Warning Letters FDA

FDA Releases COVID-19 Test Performance Data

The data compares the sensitivity of almost 200 diagnostics against a standardized set of samples.

Regulation In Vitro Diagnostics

Former MiMedX Execs Convicted On Securities Fraud Charges

The C-suite leaders schemed to falsely record shipments of unwanted products to distributors as sales so the company could meet revenue projections, the government charged.

Enforcement Commercial

US FDA Allows Dry-Heat Systems For Mask Deep Cleaning

The guidance document allows manufacturers to promote their dry-heat systems for mask bioburden reduction if they meet certain standards.

Coronavirus COVID-19 FDA

COVID-19 Serology Templates: FDA Updates Sponsor Template, Adds Home Test Document

The templates from the US agency provide guidance to manufacturers developing antibody tests for clinical or at-home use.

Coronavirus COVID-19 In Vitro Diagnostics

Hologic Aptima Assay Cleared For HIV Detection

Already cleared to monitor the viral load in HIV-positive individuals, the test has now been approved for initial diagnosis as well.

Approvals FDA
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