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Elizabeth Orr

Washington, DC

Elizabeth Orr is managing editor of US regulatory and policy for Medtech Insight, which she joined in 2015 as a reporter focused on legal issues. 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 FDANews; 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

Company Faces False Claims Charges For Disposable Rectal Probe Reuse

The Prometheus Group reportedly told health care providers that they could reuse probes that were part of its pelvic floor therapy system on multiple patients by covering them with a condom or the finger of a rubber glove.

Legal Issues Regulation

Federal Small Business Research Grant Programs At Risk Of Expiration, AdvaMed Says

The Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs will shut down on 30 September if Congress doesn’t act to renew them – but some US senators say the programs are wasteful and may funnel research overseas. 

Policy Research & Development

Watchdog Calls On FDA To Set Policy For Use Of Unauthorized Tests In Public Health Emergencies

The US Government Accountability Office reviewed how the FDA reviewed and monitored COVID-19 tests during the pandemic and found room for improvement. One particular concern was the lack of a straightforward policy on when enforcement discretion would be used. 

Coronavirus COVID-19 Policy

FDA Allows 510(k)s For HIV Diagnostics

The tests are being moved to class II, special controls, after the agency determined that would be enough to ensure device safety and efficacy.

Review Pathway Regulation

MDUFA V Passed By US House Health Subcommittee

The user fee package was among several health-related bills that the subcommittee took up on Wednesday.

Legislation FDA

FTC Tells Medtronic To Sell Intersect ENT Subsidiary To Avoid Monopoly

The move removes all regulatory roadblocks to Medtronic’s $1.1bn acquisition of Intersect ENT, which was announced in August 2021.

Regulation Commercial
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