Visby Medical’s in-office test for sexually-transmitted infections (STIs) in women that delivers 97 percent accurate results in 30 minutes — not the usual two to five days with laboratory testing — just received FDA clearance, enabling diagnosis and treatment in the same office visit.
Alfa Wassermann, a West Caldwell, N.J.-based provider of chemistry analyzers, was handed a Form 483 for device history record (DHR) issues, lack of proper procedures for use and removal of manufacturing materials, and other lapses following a September 2022 inspection by the FDA.
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.