Center for Devices and Radiological Health: Guidance Development SOP

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CDRH Transparency: 515 Program Initiative Project Status Update

<!– –> <!– Page Last Updated: 07/29/2011 –> Page Last Updated: 07/29/2011 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. Article source: http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHTransparency/ucm240318.htm

CDRH Learn: Global Harmonization: Single Audit Program

Listed below are the courses CDRH currently offers. Additional online courses are being developed and will be posted upon completion.  Course List Overview of Regulatory Requirements: Medical Devices Premarket Notification Process – 510(k) Investigational Device Exemption Process – IDE [New! 7/6/2011] Bioresearch Monitoring (BIMO) Device Establishment Registration and Listing CDRH Regulated Software: An Introduction Quality [...]

Information for Industry: X-ray Imaging Devices

<!– –> <!– Page Last Updated: 07/29/2011 –> Page Last Updated: 07/29/2011 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. Article source: http://www.fda.gov/Radiation-EmittingProducts/RadiationEmittingProductsandProcedures/MedicalImaging/MedicalX-Rays/ucm265966.htm

Class I Medical Device Recall: Global Focus Marketing & Distribution, Ltd., Silencer® S2200 Centrifuge

Recall Class: Class I Date Recall Initiated: July 15, 2011 Product: Global Focus Marketing Distribution, Ltd., Silencer® S2200 Centrifuge. The model number can be found on the front of the centrifuge and the serial number can be found on the back. Use: The Silencer® 2200 is a general purpose centrifuge designed to be used in [...]

Silencer S2200 Centrifuge by Global Focus Marketing & Distribution, Ltd.: Class I Recall

<!– –> <!– Page Last Updated: 07/27/2011 –> Page Last Updated: 07/27/2011 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. Article source: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm265707.htm

Zyvox (linezolid): Drug Safety Communication

<!– –> <!– Page Last Updated: 07/26/2011 –> Page Last Updated: 07/26/2011 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. Article source: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm265479.htm

Methylene Blue: Drug Safety Communication

[Posted 07/26/2011] AUDIENCE: Emergency Medicine, Critical Care Medicine, Psychiatry ISSUE: FDA has received reports of serious central nervous system (CNS) reactions when the drug methylene blue is given to patients taking psychiatric medications that work through the serotonin system of the brain (serotonergic psychiatric medications). A list of the serotonergic psychiatric medications that can interact [...]

FDA Drug Safety Communication: FDA alerts healthcare professionals to stop performing heart scans with CardioGen-82 due to potential for increased radiation exposure in patients

<!– –> <!– Page Last Updated: 07/26/2011 –> Page Last Updated: 07/26/2011 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. Article source: http://www.fda.gov/Drugs/DrugSafety/ucm265278.htm

FDA Drug Safety Communication: Serious CNS reactions possible when methylene blue is given to patients taking certain psychiatric medications

Safety AnnouncementAdditional Information for PatientsAdditional Information for Healthcare ProfessionalsData Summary References   here.   Although the exact mechanism of this drug interaction is unknown, methylene blue inhibits the action of monoamine oxidase A—an enzyme responsible for breaking down serotonin in the brain. It is believed that when methylene blue is given to patients taking serotonergic [...]