FDA To Impose Premarket Requirements On Blood Lancets
Single-patient lancets will face new special controls and 510(k) submission, while multiple-patient lancets would require a PMA.
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The special controls are to include biocompatibility, sterility and performance testing, as well as physician training and warning labels.
FDA issued proposed orders to remove the 510(k) exemption and establish special controls for most blood lancets, and require PMAs for one super-risky category of the finger-prick devices. The goal is to reduce infectious disease transmission.
News We’re Watching – LivaNova And Medtronic Recalls; Approvals For Abbott And Guardant; Pediatric Device Grants
Recalls on a life-support device used during heart surgery and dialysis tubing were announced this week, as were approvals for a breast cancer companion diagnostic and two cardiac ablation catheters. Additionally, the US FDA has grants available for groups that assist in pediatric device development.