On September 30, 2010, CDER’s Safe Use Initiative team convened a roundtable of more than forty experts from academia, health care management, consumer advocacy and government to address the safe use of pain medications in older adults. Background Millions of Americans suffer from chronic pain. In a study of 1000 community dwelling seniors (median age…
November 4, 2010 Approval Letter
Our STN: BLS 125300.150        Novartis Vaccines and Diagnostics, Inc.Attention: Christopher Webster, Ph.D.350 Massachusetts AvenueCambridge, MA 02139-4182  Dear Dr. Webster: We have approved your request to supplement your biologics license application for Meningococcal (Groups A, C, Y, and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine, to include revisions to the directions for product reconstitution in…
Letter to Manufacturers of External Defibrillators About Developing Safer Products
November 15, 2010 Dear External Defibrillator Manufacturer: FDA’s records have identified you as the “Official Correspondent†for the Medical Device Manufacturer stated above. Please ensure that the following message is relayed to the most responsible individual at the Medical Device Manufacturer. The Food and Drug Administration (FDA) is notifying you of our concerns relating to…
FDA Public Workshop on External Defibrillators, December 15-16, 2010
The Food and Drug Administration (FDA) is holding a public workshop to share FDA’s understanding of the risks and benefits of external defibrillators, to clarify FDA’s current expectations for how industry should identify, report, and take action on problems observed with these devices, and to promote innovation for next-generation devices that will bring safer, more…
Sigma Spectrum Infusion Pump Model 35700: Class 1 Recall: Risk of Over-Infusion
Audience: Risk Manager, Nursing Issue: FDA notified healthcare professionals of the class 1 recall of the SIGMA Spectrum Infusion Pump Model 35700. These units may fail suddenly, causing inaccurate flow conditions during use, ranging from back flow to over-infusion, including free flow. The pump does not issue an alarm when this occurs. These conditions could…
Class I Medical Device Recall: SIGMA Spectrum Infusion Pump Model 35700
Recall Class: I Date Recall Initiated: September 15, 2010 Product: SIGMA Spectrum Infusion Pump Model 35700Serial numbers ranging from 706497 to 724065 The affected units were manufactured from October 2006 to March 2008. Use: The SIGMA Spectrum Infusion Pump is intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood and blood products…
Class I Medical Device Recall: bioMérieux, Inc., VITEK 2 Gram Negative Susceptibility Cards Containing Piperacillin/Tazobactam (TZP)
Recall Class: I Date Recall Initiated: September 16, 2010 Product: VITEK 2 Gram Negative Susceptibility Cards Containing Piperacillin/Tazobactam (TZP) Affected card names and lot numbers (reference numbers) are listed in the Firm Press release under Useful Links below. See also below for link to product label photo. All lot numbers currently in distribution, as well…
Safety Investigation of CT Brain Perfusion Scans: Update 11/9/2010
Date Issued: Nov. 9, 2010 Audience: CT facilities, Emergency Medicine Physicians, Radiologists, Neurologists, Neurosurgeons, Radiologic Technologists, Medical Physicists, Radiation Safety Officers Medical Specialties: Emergency Medicine, Radiology, Neuroradiology Device: Multi-slice CT machines On Oct. 8, 2009, the FDA issued an Initial Communication about excess radiation during CT brain perfusion scans, which are used to aid in the…
Federal Register: Draft Guidance, Emergency Use Authorization of Medical Products, 66104 [2010?27160]
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Information on Products for Security Screening of People
Description Uses Risks/Benefits of General-Use X-Ray Security Systems Information for Professionals Industry Guidance Other Resources metal detectors were the only electronic products commonly used for people screening.   However, advanced imaging technologies are also available for people screening, using either millimeter waves or x-rays. These products are also referred to as: Full-body Security Scanners Advanced Imaging…