General Hospital Panel Clarification
This article was originally published in The Gray Sheet
Executive SummaryIn discussion by FDA's General Hospital and Personal Use Devices panel Sept. 14 on classification of all previously unclassified washers and washer-disinfectors intended for processing reusable devices ("The Gray Sheet" Sept. 21, p. 4), industry representative Salvadore Palomares (ICU Medical) argued to have washers classified as Class I and washer disinfectors classified as Class II. He cast a dissenting vote to the panel's Class II recommendation for both devices
You may also be interested in...
Revised bill released by the US Senate Finance Committee adjusts the manufacturer discount program in Medicare Part D and includes new provisions aimed at easing beneficiary cost sharing obligations.
Through a draft guidance, the US agency has established performance criteria for magnetic resonance coils, making the devices eligible for the standards-based Safety and Performance Based Pathway.
Singapore recalls trigger international reaction as metformin is added to growing list of chronic medications found to contain NDMA.