We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The Institute for Clinical and Economic Review (ICER) plans to take health equity into account in its product value assessments and has come up with some ideas for how to do that.
The FDA offers recommendations for using electronic systems, records and signatures in clinical trials, including advice on validation, in a draft guidance released Wednesday.
According to a new poll, 77 percent of American consumers think that the FDA should regulate medical device service and repair conducted by either original equipment manufacturers or independent third-party companies.
In a potentially “game-changing” legislative move, the Food and Drug Omnibus Reform Act of 2022 (FDORA) has given the FDA the option to rely on review of records and other information collected from a manufacturer in lieu of some types of on-site inspections.
The FDA’s fiscal 2024 budget request for the Center for Devices and Radiological Health (CDRH) of $679 million — a 7 percent increase from 2023 — aims to support the steadily increasing number of 510(k) applications, safeguard the medical device supply chain, help address the opioid crisis and improve postmarket surveillance, the agency said.
The U.S. Attorney’s Office for the Southern District of New York has indicted Laura Perryman, former CEO of Stimwave, a Florida-based medical device company, in connection with an alleged scheme for creating and selling a non-functioning medical device for implantation into patients suffering from chronic pain.
Baxter International announced that it issued an urgent medical device correction for potential patient oxygen desaturation, or low blood oxygen, under certain conditions when its Life2000 ventilation system is connected to a third-party oxygen concentrator.
The FDA has issued its first two replacement guidances — on face masks and face shields — of the 72 COVID-19-era guidances that automatically sunset after the expiration of the public health emergency on May 11.
The FDA has announced that when the COVID-19 public health emergency declaration expires on May 11, many of the 72 guidances issued to address the pandemic and that are still in effect will be revised and remain in effect, while others will be allowed to expire.