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A Humanitarian Device Exemption is an approval process provided by the United States Food and Drug Administration allowing a medical device to be marketed without requiring evidence of effectiveness. The FDA calls a device approved in this manner a "Humanitarian Use Device" (HUD).
The Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) is a piece of American regulatory legislation signed into law on July 9, 2012.It gives the United States Food and Drug Administration (FDA) the authority to collect user fees from the medical industry to fund reviews of innovator drugs, medical devices, generic drugs and biosimilar biologics.
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services.The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines ...
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In 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA) expanded the FDA's authorities and strengthened the Agency's ability to safeguard and advance public health. Among other authorities, FDASIA permitted FDA to publish regulations establishing a Unique Device Identification (UDI) system for medical devices.
FDA classification of soft contact lens materials [13] FDA lens group Adopted name Transmissibility level (Dk x10-11) Water content Chemical composition I non-ionic low water content: galyfilcon A 60 47% – lotrafilcon A 140 24% DMA, siloxane, TRIS: lotrafilcon B 110 33% polymacon: 7.5 36% HEMA: tetrafilcon 9.0 43.5% HEMA, MMA, NVP: II non-ionic