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...
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.
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