The FDA unveiled final recommendations for how medical devices should be designed to interact with other devices and IT systems. Source: The GMP Letter

The FDA issued flagged six device manufacturers for issues ranging from responses to customer complaints to record-keeping. Source: The GMP Letter

The FDA issued warning letters to five device manufacturers for a range of issues, including a failure to seek pre-market approval, to apply for modified intended uses, and quality violations.…

With the recall of 465,000 Abbott pacemakers deemed at risk of getting hacked — marking the first ever device recall for a cybersecurity issue — it’s time for a deeper…

The Cook County Circuit Court revived a 2013 lawsuit against DePuy Orthopaedics and Premier Orthopaedics Sales alleging negligence in designing a hip replacement device. Source: The GMP Letter

In the first ever recall for a cybersecurity risk, Abbott recalled 465,000 implantable pacemakers for a firmware update to reduce the risk of unauthorized access. The update requires an in-person…

A company that manufactures EpiPens neglected to follow up on hundreds of complaints that the epinephrine injectors failed to operate during life-threatening emergencies, including some that resulted in patients’ deaths…

The FDA rolled out its new Premarket Approval Application Critical to Quality pilot program, created to give PMA applicants the option to speak with the FDA on development of CtQ…

The Department of Homeland Security issued an advisory over major software vulnerabilities in two versions of Philips Healthcare’s web application DoseWise Portal (DWP) that can give hackers access to protected…

The FDA said it could find no evidence that tubes made by Becton Dickinson for Magellan Diagnostics’ blood lead-level testing devices contributed to inaccurate readings from the devices, which Magellan…