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.
CINCINNATI — With September’s deadline for displaying unique device identifiers on high-risk devices just around the corner, rollout for many manufacturers is well underway. Read More
The FBI has warned healthcare providers to expect an upsurge in cybercrimes against health information systems and to make sure medical devices aren’t causing vulnerabilities in their networks. Read More
Routine quality system surveillance inspections of foreign devicemakers increased by 93 percent in 2012, according to newly released FDA data. Read More
CINCINNATI — CDRH’s Office of Compliance expects to begin work on a public database of device quality information, such as MDR reports, by the end of the year, OC Director Steven Silverman told devicemakers Wednesday at the FDA/Xavier University MedCon conference. Read More
As the July 22 deadline for complying with new EU requirements on hazardous substances approaches, some manufacturers of medical devices and active implantable medical devices are feeling a financial squeeze. Read More
The FDA is proposing a voluntary program to speed the approval of medical technologies that address unmet needs for life-threatening and irreversibly debilitating diseases. Read More