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Heightened Standards Proposed For Finger-Prick Devices

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.

FDA took the next step to raise the regulatory standards for blood lancets in response to concerns about spreading infectious disease.

The devices used to prick a patient's finger for a blood sample have been reaching the market for years as class I products with no need for a 510(k)

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