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.
The five products include a conditioning tool for eating disorders, a system that evaluates the properties of esophogeal tissue, and a tool used to measure the strain on an orthopedic implant during surgery.