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
In this week’s podcast, senior reporter Ferdous Al-Faruque gives an early look at how user fee negotiations between the US FDA and industry groups for MDUFA V are unfolding. As in the past, the parties are at odds over how much industry should pay, and what the FDA is using the money for.
The settlement resolves allegations the neurosurgeon collected kickbacks both for using Medtronic devices and for buying devices through his own distributorships.
The all-day event will include sessions on Medical Device Reports, recalls and Sec. 522 postmarket studies.
The US government says the five conspirators solicited medically unnecessary orders for braces through bribes and kickbacks.
Medical device manufacturers including Medtronic, Boston Scientific and Cook Medical could get payment boosts for the first time in fiscal 2022, while several other manufacturers will see their add-on payments extended for another year.
A 2018 interim rule won’t be finalized for another year so regulators have more time to review the proposal and related stakeholder comments.