As part of its Medical Device User Fee Amendments (MDUFA) goals for 2023-2027, the FDA’s Center for Diagnostic and Radiological Health (CDRH) has added new functions to its portal where device sponsors can send in and track their premarket submissions.
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.