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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

FDA To Lower Scrutiny Of CMV Tests Used In Transplant Patients

A proposed rule from the US agency would move the in vitro diagnostics from high-risk class III to class II with special controls, eliminating the requirement for a PMA.

Regulation Review Pathway

International Harmonization: Not Just For Audits Anymore

The International Medical Device Regulators Forum, perhaps most notorious for its efforts to standardize audit processes between nations with its Medical Device Single Audit Program, is also focusing on harmonizing device reviews and adverse event codes.

International Regulation

FDA Gives Insight On Changing Approval Landscape

Device center officials at the US agency focused on new approval pathways at RAPS Convergence 2020.

Regulation Approvals

Consensus Standards: FDA Guidance Describes Recognition Process

The 13-page guidance document lays out what the agency looks for in deciding which consensus standards it can rely upon for premarket submissions.

Regulation Standards

FDA: Two-Step Test Can Find Reg Status Of Non-Device Functions

To determine how non-device functions are regulated, the US agency looks at what kind of effect they have on the device itself.

Digital Health FDA

COVID-19: CDRH Staff Leaves Door Open For Some LDT Safety Oversight

US FDA staff spoke on HHS’s new laboratory developed test edict, as well as ongoing concerns around new test types and reviewer responsiveness in a recent virtual town hall.

FDA Policy
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