CDRH is seeking a contractor to study rapid molecular diagnostic methods for detecting influenza, as it considers using them as faster and more accurate reference methods for premarket evaluation of influenza diagnostics.
An industry group is advising the FDA to not regulate certain mobile health (mHealth) products, which can include medical smart phone applications, because their “social benefit” outweighs their inherent low risk.
Beckman Coulter, Inc., Synchron LX Clinical Systems Ion Selective Electrolyte (ISE) Flow Cell: Class I Recall - Incorrect Electrolyte ResultsMay 23, 2011 11:30 am | by U.S. Food & Drug Administration | News | Comments
Errors may be the result of ratio pump wear, silver iodide build-up on the chloride electrode, microbial contamination, and instrument maintenance.
Dietary supplement product packaging may cause it to be confused with an antibiotic product.
Class I Medical Device Recall: Beckman Coulter, Inc., Synchron LX Clinical Systems Ion Selective Electrolyte (ISE) Flow CellMay 23, 2011 9:30 am | by U.S. Food & Drug Administration | News | Comments
Reason for Recall: There may be ratio pump wear, silver iodide build-up on the chloride electrode, microbial contamination, general non-ISE hardware, and maintenance in the instruments (ion selective electrolyte flow cell) which may cause incorrect...
Feeding this product to infants may result in necrotizing enterocolitis, a life-threatening condition resulting in necrosis of intestinal tissue.
The Abbott RealTime HCV assay is a laboratory test that measures the amount of hepatitis C viral RNA in the blood of an individual infected with the hepatitis C virus (HCV).
Labeling, Approval Order, and Summary of Safety and Effectiveness for Abbott RealTime HCV (P100017).
Consumer Information on: VITROS & #xae; Immunodiagnostic Products HBeAg Reagent Pack, Calibrator and Controls - P090028May 19, 2011 12:30 pm | by U.S. Food & Drug Administration | News | Comments
VITROS® Immunodiagnostic Products HBeAg Immunoassay is a laboratory test used to detect hepatitis B e antigen associated with the hepatitis B virus (HBV)2 infection.
Summary Information for: VITROS & #xae; Immunodiagnostic Products HBeAg Reagent Pack, Calibrator and ControlsMay 19, 2011 12:30 pm | by U.S. Food & Drug Administration | News | Comments
Labeling, Approval Order, and Summary of Safety and Effectiveness for VITROS® Immunodiagnostic Products HBeAg Reagent Pack, Calibrator and Controls (P090028).
The candidate would be part of a collaborative team in the Division of Chemistry and Materials Science (DCMS), in the Office of Science and Engineering Labs (OSEL), at the Center for Devices and Radiological Health (CDRH) at FDA
Draft Guidance for Industry and Food and Drug Administration Staff - Class II Special Controls Guidance Document: In Vitro Diagnostic Devices for Bacillus spp. DetectionMay 18, 2011 6:31 am | by U.S. Food & Drug Administration | News | Comments
This draft special controls guidance document was developed to support the proposed classification of in vitro diagnostic device for Bacillus spp. detection, a previously unclassified type of preamendments device, into class II, as recommended by the...
Zevex International has received an FDA warning letter citing problems with its corrective and preventive action (CAPA) procedures and software fixes.
An FDA advisory panel has backed BioMimetic Therapeutics’ investigational bone graft device, which uses a growth factor protein to regrow bones in the foot and ankle, despite FDA questions about the intended patient population.
Product marketed as a dietary supplement contains sibutramine, which may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.
FDA inspection revealed products mimic antibiotics readily available in Mexico and possibly familiar to Hispanic consumers.
Labels on these devices state that they are â€œSterileâ€; however, they were stolen prior to being sterilized and are non-sterile.
Product marketed as dietary supplement contain drug ingredient sulfoaildenafil, which may interact with nitrates found in some prescription drugs and lower blood pressure to dangerous levels.
The Food and Drug Administration (FDA) is announcing a public workshop entitled: "Reprocessing of Reusable Medical Devices Workshop.' The purpose of the workshop is to discuss factors affecting the reprocessing of reusable medical devices
Federal Register: Draft Guidance for Industry and FDA Staff; Availability: Processing/Reprocessing Medical Devices in Health Care Settings; Validation Methods and LabelingMay 2, 2011 4:30 am | by U.S. Food & Drug Administration | News | Comments
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance document entitled "Draft Guidance for Industry and FDA Staff: Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."
These are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions for March 2011.
The FDA is announcing a public workshop to discuss factors affecting the quality of reprocessing of reusable medical devices, and FDA?s plans to address the identified issues. This workshop is part of an ongoing FDA effort to address patient exposure to..
Reusable medical devices are devices that health care providers can reuse to diagnose and treat multiple patients. Examples of reusable medical devices include surgical forceps, endoscopes and stethoscopes.
The Food and Drug Administration Modernization Act of 1997 (FDAMA) added the "De Novo" classification option as an alternate pathway to classify certain new devices that had automatically been placed in Class III due to lack of a predicate.
The purpose of the workshop is to provide a forum for discussion among FDA, governmental agencies, academia, physicians and various stakeholders with expertise in epidemiology, statistics, diagnostics and biomedical research to advance the methodologies f