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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

Class I Recall On Edwards Sapien 3 Ultra Valve System

An ongoing recall of Edwards Lifesciences’ Sapien 3 Ultra transcatheter heart valve system has been elevated to Class I, indicating the US FDA’s highest risk level.

Recalls Cardiology

Pediatric Scoliosis Device Nabs HDE Approval

The US FDA has approved Zimmer Biomet’s Tether device, which is the first device of its type cleared to treat children with a form of spinal curvature. It's also the first pediatric spinal device to net Humanitarian Device Exemption approval from the agency in 15 years, the company says.

Orthopedics Approvals

Ambu Settles US Defense Department False-Claims Allegations

Danish device-maker Ambu has agreed to pay $3.3m to resolve allegations of False Claims Act violations. The company is said to have made medical product in Malaysia and China for sale to the Departments of Defense and Veterans Affairs, which is forbidden under the Trade Agreements Act.

Enforcement Policy

Combination Product Reporting Rule Set For 2020 Enforcement

US FDA's long-delayed final rule on postmarketing safety reporting will mostly go into effect next July, though manufacturers who file reports via the Vaccine Adverse Event Reporting System have a little extra time, with their compliance date set for 31 January 2021.

Combination Products Post Market Regulation & Studies

Combination Product Reporting Rule Set For 2020 Enforcement

Most combination product applicants will need to comply with an FDA final rule on postmarketing safety reporting as of 31 July 2020.

Post Market Regulation & Studies Guidance Documents

J&J Wins Dismissal Of Silicone Implant Suit

Johnson & Johnson subsidiary Mentor Worldwide won’t have to face lawsuits filed by women who say they were injured by the company’s MemoryGel silicone breast implants. A California federal court ruled that FDA preemption blocked the suits.

Legal Issues Policy
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