FDA To Impose Premarket Requirements On Blood Lancets
Executive Summary
Single-patient lancets will face new special controls and 510(k) submission, while multiple-patient lancets would require a PMA.
You may also be interested in...
Power Morcellation Containment Devices Placed In FDA Class II
The special controls are to include biocompatibility, sterility and performance testing, as well as physician training and warning labels.
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.
Industry And Investors Ponder Legacy Of Theranos Scandal
What lessons can be learned from the conviction of Theranos founder Elizabeth Holmes, found guilty on four counts of investor fraud in a US court on 4 January?