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Summary Information for: Elecsys & #xae; Anti-HBc IgM Immunoassay and Elecsys & #xae; PreciControl Anti-HBc IgM for use on the cobas e 411 Immunoassay Analyzer

January 10, 2012 5:31 am | by U.S. Food & Drug Administration | News | Comments

Labeling, Approval Order, and Summary of Safety and Effectiveness for Elecsys® Anti-HBc IgM Immunoassay and Elecsys® PreciControl Anti-HBc IgM for use on the cobas e 411 Immunoassay Analyzer (P110031).

Endo Pharmaceuticals Opiate Products by Novartis Consumer Health: Public Health Advisory - Potential Safety Risk

January 9, 2012 6:30 am | by U.S. Food & Drug Administration | News | Comments

A packaging problem may result in a pill, tablet or caplet getting mixed in with a different prescription.

Novartis Consumer Health Over-The-Counter Products: Recall - Potential Presence of Foreign Tablets or Chipped or Broken Tablets or Gelcaps

January 9, 2012 5:30 am | by U.S. Food & Drug Administration | News | Comments

Consumers are asked to either destroy or return unused product identified in the recall to Novartis.

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Micro-sample Viscometer Selected for FDA Nanotechnology Toxicology Studies

January 9, 2012 4:55 am | News | Comments

The FDA's National Center for Toxicological Research (NCTR) has purchased a micro-sample viscometer, VISCOLab 5000, to better characterize and detect nanoscale materials. The agency's research involves the manipulation of biological buffers in saline solutions with tissue culture media...

IOM Argument to End 510(k)s Is Defended in FDLI Report

January 6, 2012 2:33 pm | by U.S. Food & Drug Administration | News | Comments

The FDA should establish a new standard for premarket clearance to tell the difference between products that can be approved based on predicate devices alone and those that need more rigorous postmarket approval, says one legal expert.

EU Proposes Centralized Expert Group to Oversee Medical Devices(2)

January 6, 2012 2:32 pm | by U.S. Food & Drug Administration | News | Comments

A group of medical device experts from EU member states would oversee device regulation in the union, according to one proposal in a recent “roadmap” released by the European Commission’s Directorate-General for Health & Consumers.

Regulatory Harmonization Institute: First Not-For-Profit Organization Dedicated to Global Harmonization of Drug and Medical Device Regulatory Requirements

January 5, 2012 5:24 am | News | Comments

ELMWOOD PARK, N.J.--(BUSINESS WIRE)--The Regulatory Harmonization Institute, Inc. (RHI) an international, not-for-profit association dedicated to global harmonization of drug and medical device regulatory requirements, today announced the launch of its Web site, programs and initiatives...

Ikaria INOmax DS Drug Delivery System: Class I Recall - Erratic Nitric Oxide (NO) Readings

January 4, 2012 11:30 am | by U.S. Food & Drug Administration | News | Comments

Adverse consequences may include hypoxia, hypotension, bradycardia, cardiac arrest, organ damage, acute respiratory distress syndrome (ARDS), neurological deficits, or death.

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Class I Medical Device Recall: Ikaria INOmax DS Drug Delivery System

January 4, 2012 8:31 am | by U.S. Food & Drug Administration | News | Comments

Reason for Recall: Fretting corrosion at the electrical contact interface of certain metals was the root cause for erratic nitric oxide (NO) monitoring readings. Adverse consequences may include inadequate oxygen reaching the tissues in the body...

Devicemakers Schooled on How to Respond to Off-Label Information Requests

December 30, 2011 4:31 pm | by U.S. Food & Drug Administration | News | Comments

Devicemakers responding to unsolicited requests for off-label product information are urged to keep conversations private and specific to the requester’s inquiry, according to a new FDA draft guidance.

FDA Devises Flow Chart to Guide 510(k) Evaluations

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

Concerns about the future of the FDA’s 510(k) process appear to have been put to rest with the year-end issuance of a draft guidance on evaluating substantial equivalence in 510(k)s.

Draft Guidance for Industry and Food and Drug Administration Staff - Medical Device Classification Product Codes

December 30, 2011 3:31 am | by U.S. Food & Drug Administration | News | Comments

Since the May 28, 1976 Medical Device Amendments were passed, the Classification Regulation Panels (21 CFR 862-892) have been the basis for the Center for Devices and Radiological Health?s (CDRH) Classification Product Code structure and organization.

CareFusion AVEA Ventilator: Recall - Failure May Lead to Lack of Ventilation

December 23, 2011 12:30 pm | by U.S. Food & Drug Administration | News | Comments

Ventilator may stop ventilating and result in life-threatening injury or death.

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Class I Medical Device Recall: CareFusion AVEA Ventilator

December 23, 2011 8:30 am | by U.S. Food & Drug Administration | News | Comments

Reason for Recall: The AVEA ventilator can develop a failure where the ventilator activates a false Extended High Ppeak alarm, opens the safety valve and stops ventilating. Without health care professional intervention, patients may suffer...

Liquid Acetaminophen marketed for infants: Drug Safety Communication - Potential for Dosing Errors

December 22, 2011 11:30 am | by U.S. Food & Drug Administration | News | Comments

Additional concentration of liquid acetaminophen marketed for “infants” (160 mg/5 mL) is now available.

Eclectic Institute Dietary Supplements: Recall - Possible Salmonella Contamination

December 22, 2011 8:31 am | by U.S. Food & Drug Administration | News | Comments

Salmonella can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

ShoulderFlex Massager: Warning - Risk of Strangulation

December 21, 2011 10:31 am | by U.S. Food & Drug Administration | News | Comments

Hair, clothing or jewelry can become entangled in the ShoulderFlex Massager and cause serious injury or even death from strangulation.

St. Jude Medical, Riata and Riata ST Silicone Endocardial Defibrillation Leads: Class 1 Recall - Failures with Lead Insulation

December 21, 2011 3:31 am | by U.S. Food & Drug Administration | News | Comments

Premature insulation abrasion may cause the conductors to become externalized, which can cause serious adverse health consequences, including death.

Gilenya (fingolimod): Drug Safety Communication - Safety Review of a Reported Death After the First Dose

December 20, 2011 10:31 am | by U.S. Food & Drug Administration | News | Comments

Patients with MS should not stop taking Gilenya without talking to their healthcare professional.

Guidance for Industry and Food and Drug Administration Staff - Enforcement Policy for Premarket Notification Requirements for Certain In Vitro Diagnostic and Radiology Devices

December 20, 2011 3:30 am | by U.S. Food & Drug Administration | News | Comments

This document is intended to describe FDA?s intent with regard to enforcement of premarket notification (510(k)) requirements for certain in vitro diagnostic and radiology devices under 21 CFR Part 807, Subpart E. FDA intends to propose the...

Lawmakers Concerned About Medical Device Safety

December 19, 2011 10:15 am | News | Comments

WASHINGTON, D.C. – Representatives Edward J. Markey (D-Mass.), Diana DeGette (D-Colo.), Henry A. Waxman (D-Calif.), Jan Schakowsky (D-Ill.), and Rosa DeLauro (D-Conn.) today sent a letter to the Commissioner of the Food and Drug Administration (FDA) raising concerns about flaws...

Summary Information for: AtriCure Synergy Ablation System

December 19, 2011 4:31 am | by U.S. Food & Drug Administration | News | Comments

Labeling, Approval Order, and Summary of Safety and Effectiveness for AtriCure Synergy Ablation System (P100046).

Consumer Information on: AtriCure Synergy Ablation System - P100046

December 19, 2011 4:31 am | by U.S. Food & Drug Administration | News | Comments

The AtriCure Synergy Ablation System is used to destroy (ablate) heart tissue that is beating abnormally. It includes the Synergy Ablation Clamp, a handheld surgical device that destroys the heart tissue that is grasped between the clamp?s jaws during...

Clinical Trial Bias Questions Halt CardioMEMS at Circulatory Panel

December 16, 2011 12:32 pm | by U.S. Food & Drug Administration | News | Comments

A negative devices advisory panel opinion, based on inconsistencies in clinical trials, may jeopardize a hoped-for buy-in by St. Jude Medical for the CardioMEMS monitoring device for heart failure.

Sunshine Act Compliance Delayed to 2013 Under CMS Proposed Rule

December 16, 2011 12:31 pm | by U.S. Food & Drug Administration | News | Comments

Devicemakers no longer need to meet a Jan. 1 Sunshine Act deadline for reporting payments to doctors and hospitals.

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