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FDA Considers Reference Method for Influenza Diagnostics

May 27, 2011 2:31 pm | by U.S. Food & Drug Administration | News | Comments

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.

Industry Advises No FDA Regulation for Some mHealth Devices

May 27, 2011 2:31 pm | by U.S. Food & Drug Administration | News | Comments

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 Results

May 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.

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Pentrexyl Forte Natural: Recall - Misleading Packaging

May 23, 2011 10:30 am | by U.S. Food & Drug Administration | News | Comments

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 Cell

May 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...

SimplyThick: Public Health Notification - Risk of Life-Threatening Bowel Condition

May 20, 2011 2:30 pm | by U.S. Food & Drug Administration | News | Comments

Feeding this product to infants may result in necrotizing enterocolitis, a life-threatening condition resulting in necrosis of intestinal tissue.

Consumer Information on: Abbott RealTime HCV - P100017

May 20, 2011 7:34 am | by U.S. Food & Drug Administration | News | Comments

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).

Summary Information for: Abbott RealTime HCV

May 20, 2011 7:34 am | by U.S. Food & Drug Administration | News | Comments

Labeling, Approval Order, and Summary of Safety and Effectiveness for Abbott RealTime HCV (P100017).

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Consumer Information on: VITROS & #xae; Immunodiagnostic Products HBeAg Reagent Pack, Calibrator and Controls - P090028

May 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 Controls

May 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).

CDRH OSEL Recruitment for ORISE: Post-doctoral researcher in Polymer Chemistry

May 18, 2011 9:33 am | by U.S. Food & Drug Administration | News | Comments

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. Detection

May 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 Warning Letter Cites CAPA, Software Issues

May 13, 2011 1:31 pm | by U.S. Food & Drug Administration | News | Comments

Zevex International has received an FDA warning letter citing problems with its corrective and preventive action (CAPA) procedures and software fixes.

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Panel Backs Bone Graft Device Despite FDA Concerns

May 13, 2011 1:30 pm | by U.S. Food & Drug Administration | News | Comments

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.

Slim Xtreme Herbal Slimming Capsule: Undeclared Drug Ingredient

May 11, 2011 5:30 am | by U.S. Food & Drug Administration | News | Comments

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.

Multi-Mex Distributor Inc. Dietary Supplements: Recall - Product Packaging Mimics OTC Antibiotics

May 10, 2011 5:30 am | by U.S. Food & Drug Administration | News | Comments

FDA inspection revealed products mimic antibiotics readily available in Mexico and possibly familiar to Hispanic consumers.

Boston Scientific Devices Stolen – Risk of Infection

May 4, 2011 4:30 am | by U.S. Food & Drug Administration | News | Comments

Labels on these devices state that they are “Sterile”; however, they were stolen prior to being sterilized and are non-sterile.

Regenerect: Recall - Undeclared Drug Ingredient

May 2, 2011 8:30 am | by U.S. Food & Drug Administration | News | Comments

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.

Federal Register: Reprocessing of Reusable Medical Devices; Public Workshop

May 2, 2011 4:30 am | by U.S. Food & Drug Administration | News | Comments

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 Labeling

May 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."

PMA Final Decisions for March 2011

April 29, 2011 11:30 am | by U.S. Food & Drug Administration | News | Comments

These are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions for March 2011.

Public Workshop - Reprocessing of Reusable Medical Devices, June 8-9, 2011

April 29, 2011 8:30 am | by U.S. Food & Drug Administration | News | Comments

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..

Information on Reprocessing of Reusable Medical Devices

April 29, 2011 8:30 am | by U.S. Food & Drug Administration | News | Comments

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.

Evaluation of Automatic Class III Designation (De Novo) Decision Summaries (Added K101699)

April 29, 2011 7:30 am | by U.S. Food & Drug Administration | News | Comments

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.

Public Workshop - Study Methodologies for Diagnostics in the Postmarket Setting, May 12, 2011

April 28, 2011 6:30 am | by U.S. Food & Drug Administration | News | Comments

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

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