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Perfect Image Solutions Topical Hair Regrowth Products: Recall - Unapproved Drugs, Risk of Health Hazards

January 20, 2012 10:30 am | by U.S. Food & Drug Administration | News | Comments

Systemic absorption of topically administered Minoxidil could cause low blood pressure, heart palpitations and associated cardiac symptoms.

Vagifresh Ball, Vagifresh Gel, Female One: Recall - Undeclared Drug Ingredient, Bacterial Contamination

January 20, 2012 9:30 am | by U.S. Food & Drug Administration | News | Comments

Possibility of an adverse reaction or unknown drug-drug interaction.

Consumer Information on: GORE TAG Thoracic Endoprosthesis - P040043/S040

January 19, 2012 5:31 am | by U.S. Food & Drug Administration | News | Comments

The GORE TAG Thoracic Endoprosthesis is an artificial endovascular stent graft and is used to treat isolated lesions, excluding dissections, of the descending thoracic aorta during endovascular repair. Some of the complex isolated lesions include...

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Summary Information for: GORE TAG Thoracic Endoprosthesis

January 19, 2012 5:30 am | by U.S. Food & Drug Administration | News | Comments

Labeling, Approval Order, and Summary of Safety and Effectiveness for GORE TAG Thoracic Endoprosthesis (P040043S040).

Interstate Specialty Products Receives ISO 13485 Certification

January 19, 2012 4:51 am | News | Comments

Sutton, MA – Interstate Specialty Products, Inc., a manufacturer of high performance custom gaskets and provider of custom die-cutting services, recently received ISO 13485 certification for their quality management system. ISO 13485 is an international standard thatspecifies requirements...

Grifols Receives ISO 13485:2003+AC:2009 Quality Management Certification for its Medical Devices

January 18, 2012 4:50 am | News | Comments

LOS ANGELES/PRNewswire/ -- Grifols, a global healthcare company and biopharmaceutical manufacturer based in Barcelona, Spain, announced that its U.S. diagnostic and hospital divisions have received ISO 13485:2003+AC:2009 certification, an international quality standard...

Evaluation of Automatic Class III Designation (De Novo) Decision Summaries: K102333 added

January 14, 2012 9:31 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.

FDA Asks TV Mesh Manufacturers to Conduct Postmarket Studies

January 13, 2012 1:31 pm | by U.S. Food & Drug Administration | News | Comments

Surgical mesh manufacturers have until Feb. 3 to submit their plans to the FDA for conducting postmarket studies under Section 522 of the 1938 FD&C Act.

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MDUFA Agreement Progresses, But Sticking Points Remain

January 13, 2012 1:31 pm | by U.S. Food & Drug Administration | News | Comments

FDA-industry negotiations to reauthorize the Medical Device User Fee Act (MDUFA) went down to the wire last week, as CDRH seemed destined to miss a Jan. 15 due date for sending a commitment letter to Congress.

Adcetris (brentuximab vedotin): Drug Safety Communication - Progressive Multifocal Leukoencephalopathy and Pulmonary Toxicity

January 13, 2012 7:31 am | by U.S. Food & Drug Administration | News | Comments

New Boxed Warning and Contraindication highlighting these risks added to product labeling.

Bedford Laboratories Polymyxin B For Injection USP And Vecuronium Bromide For Injection: Recall - Glass Particles

January 12, 2012 8:31 am | by U.S. Food & Drug Administration | News | Comments

Particulate matter in injections can be harmful when introduced into the bloodstream.

Innovation Pathway

January 12, 2012 6:30 am | by U.S. Food & Drug Administration | News | Comments

The Innovation Pathway aims to shorten the overall time it takes for the development, assessment, and review of breakthrough medical devices.

Consumer Information on: Berlin Heart EXCOR & #xae; Pediatric Ventricular Assist Device (VAD) - H100004

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

The EXCOR® Pediatric VAD is a blood pump that vibrates rhythmically and is designed to assist patients who cannot pump enough blood with their own natural heart. The device can be used in patients who cannot effectively pump blood with their left and/or..

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Consumer Information on: Elecsys & #xae; Anti-HBc IgM Immunoassay and Elecsys & #xae; PreciControl Anti-HBc IgM for use on the cobas e 411 Immunoassay Analyzer - P110031

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

The Elecsys® Anti-HBc IgM Immunoassay is a laboratory test used to detect antibodies associated with the hepatitis B virus (HBV) infection. Antibodies are proteins produced by the body to fight against foreign substances, such as viruses and bacteria...

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.

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.

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.

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