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Brazil’s National Agency for Sanitary Surveillance is streamlining its process for good manufacturing practice certification to allow faster access to new technologies. Read More
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. Read More
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 dive on how to protect your product from cyber risk. Read More
The Cook County Circuit Court revived a 2013 lawsuit against DePuy Orthopaedics and Premier Orthopaedics Sales alleging negligence in designing a hip replacement device. Read More
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 visit with a healthcare provider. Read More
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 — and the company did not recall potentially defective injectors from the marketplace even after identifying a fault in a critical injector component, the FDA said in a warning letter. Read More
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 controls for their devices and to forego the standard PMA pre-approval inspection. Read More