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Medtronic has issued a warning to healthcare providers that its Model B35200 Percept PC implantable neurostimulator might fail following a cardioversion procedure for treatment of cardiac arrhythmia. Read More
Vertex Pharmaceuticals will submit an Investigational New Device (IND) application next year for a drug/device combination that delivers insulin-producing, lab-created islet cells in a membrane packet to protect them from the body’s immune system. Read More
The International Medical Device Regulators Forum (IMDRF) is seeking comments on a draft guidance on machine learning-enabled medical devices (MLMD) that aims to “support global harmonization and provide a foundation of future guidelines.” Read More
The FDA reminded in vitro diagnostic (IVD) makers that they must get Institutional Review Board (IRB) approval for clinical studies of IVDs that involve human subjects, including those using leftover, deidentified human specimens in FDA-regulated studies. Read More
Magnolia Medical Technologies, developer of the Steripath Gen 2 blood collection system, drew a warning letter from the FDA for qualify failures observed during a June 3 to July 15 inspection of its Seattle premises. Read More
The Advanced Medical Technology Association (AdvaMed) has proposed a modified plan for the Centers for Medicare & Medicaid Services (CMS) to pay for breakthrough devices, after the agency withdrew its proposal to do so. Read More
Managing corrective and preventive action (CAPA) activities is a perennial problem for device manufacturers. Complaints, nonconformances, out-of-specification results all should generate a CAPA file, but the FDA continues to find fault with the way they are handled. Chances are, if you received a 483 at your last inspection, the words “corrective action” appeared prominently on the form. If they did, was your response detailed and specific enough to satisfy the FDA? Read More
The FDA has called on manufacturers of ENFit low-dose tip (LDT) syringes to update their labeling to reduce the risk that their products will lead to accidental overdoses. Read More