Latest Federal Register Notices
Class 2 for Prostate Tissue Jet System
Federal Register notice: FDA classifies the fluid jet system for prostate tissue removal into Class 2 (special controls). 06/15/2018
Draft Guide on Certain Guidewire Submissions
Federal Register notice: FDA makes available a draft guidance entitled “Coronary, Peripheral, and Neurovascular Guidewires — Performance Tests and Recommended Labeling.” 06/15/2018
Guide on Intravascular Catheters, Wires with Lubricious Coatings
Federal Register notice: FDA makes available a draft guidance entitled “Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings—Labeling Considerations.” 06/15/2018
2 Ferring Menotropins ANDAs Withdrawn
Federal Register notice: FDA withdraws approval of two Ferring Pharmaceuticals ANDAs because the company notified the agency that they were no longer marketed. 06/15/2018
Brain Trauma Assessment Tests are Class 2
Federal Register notice: FDA classifies brain trauma assessment tests into Class 2 (special controls). 06/14/2018
Endoscopic Cutting Systems Placed in Class 2
Federal Register notice: FDA classifies the endoscopic electrosurgical clip cutting system into Class 2 (special controls). 06/14/2018
Draft Guide on Patient-Focused Drug Development
Federal Register notice: FDA makes available a draft guidance entitled “Patient-Focused Drug Development: Collecting Comprehensive and Representative Input.” 06/14/2018
Draft Guide on Humanitarian Device Exemption Program
Federal Register notice: FDA makes available a draft guidance entitled “Humanitarian Device Exemption (HDE) Program.” 06/14/2018