Wipro GE Healthcare Private Ltd. recalls its Care Plus and Lullaby Incubators due to the devices bedside panel or porthole not properly latching close...
Reuters reports that FDA investigators found animal research issues at a Neuralink facility in California.
Federal Register notice: FDA sends to OMB an information collection revision entitled Medical Device User Fee Cover Sheet, Form FDA 3601 and Device Fa...
Federal Register notice: FDA sends to OMB an information collection revision entitled Export Certificates for FDA Regulated Products.
FDA issues safety alert on a higher-than-expected risk of device failure with DT MedTechs Hintermann Series H3 Total Ankle Replacement system.
CBER director Peter Marks says he expects 2024 to be a big year for gene therapy approvals as several Center initiatives take hold to advance product ...
Four stakeholders update comments on the latest version of an FDA draft guidance on topical ophthalmic products.
Three stakeholder organizations raise many questions about and objections to an FDA proposed rule on wound products.
