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Summary Information for: VITROS Immunodiagnostic Products Anti-HBe Reagent Pack, VITROS Immunodiagnostic Products Anti-HBe Calibrator, and VITROS Immunodiagnostic Products Ant...

August 1, 2011 9:32 pm | by U.S. Food & Drug Administration | News | Comments

Labeling, Approval Order, and Summary of Safety and Effectiveness for VITROS Immunodiagnostic Products Anti-HBe Reagent Pack, VITROS Immunodiagnostic Products Anti-HBe Calibrator, and VITROS Immunodiagnostic Products Anti-HBe Controls (P100001).

GEM Premier 4000 PAK Cartridges for Use on the GEM Premier 4000 System: Class I Recall - Innaccurate Results

August 1, 2011 6:30 am | by U.S. Food & Drug Administration | News | Comments

Potassium test results too low when compared to a reference analyzer, which may lead to inappropriate patient treatment and may cause serious adverse health consequences, including death.

CDRH Transparency: 515 Program Initiative Project Status Update - Implantable Pacemaker Pulse Generator Step 3(3)

July 29, 2011 6:31 pm | by U.S. Food & Drug Administration | News | Comments

FDA issues proposed rule, which proposes classification of device type into Class I, II, or III

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Devicemakers Want Time To Review CMS & #8220;Sunshine & #8221; Payment Data(2)

July 29, 2011 6:31 pm | by U.S. Food & Drug Administration | News | Comments

AdvaMed has submitted a slew of suggestions to the Centers for Medicare & Medicaid Services (CMS) on the agency’s implementation of the sunshine provision of healthcare reform, including a 45-day preview period and using categories of products rather than individual products.

CAD Software Found Ineffective for Detecting Breast Cancers(3)

July 29, 2011 6:30 pm | by U.S. Food & Drug Administration | News | Comments

Computer-aided detection (CAD) software, in wide use today to help analyze and interpret mammograms, does not improve the accuracy of detection, according to a new study.

Information for Industry: X-ray Imaging Devices

July 29, 2011 12:31 pm | by U.S. Food & Drug Administration | News | Comments

Compliance testing for required performance characteristics is specified in 21 CFR 1020.30-1020.33 ("Diagnostic x-ray systems and their major components;" "Radiographic equipment;" "Fluoroscopic equipment;" and "Computed tomography (CT) equipment").

Zyvox (linezolid): Drug Safety Communication - Serious CNS Reactions Possible When Given to Patients Taking Certain Psychiatric Medications

July 26, 2011 11:30 am | by U.S. Food & Drug Administration | News | Comments

Symptoms may include mental changes (confusion, hyperactivity, memory problems), muscle twitching, excessive sweating, shivering or shaking, diarrhea, trouble with coordination and/or fever.

Methylene Blue: Drug Safety Communication - Serious CNS Reactions Possible When Given to Patients Taking Certain Psychiatric Medications

July 26, 2011 11:30 am | by U.S. Food & Drug Administration | News | Comments

Symptoms may include mental changes (confusion, hyperactivity, memory problems), muscle twitching, excessive sweating, shivering or shaking, diarrhea, trouble with coordination and/or fever.

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Multaq (dronedarone): Drug Safety Communication - Increased Risk of Death or Serious Cardiovascular Events

July 21, 2011 6:30 pm | by U.S. Food & Drug Administration | News | Comments

FDA reviewing data from a clinical trial.

Oral Osteoporosis Drugs (bisphosphonates): Drug Safety Communication - Potential Increased Risk of Esophageal Cancer

July 21, 2011 9:31 am | by U.S. Food & Drug Administration | News | Comments

FDA is reviewing data from published studies to evaluate risk of cancer of the esophagus.

Unique Device Identification (UDI) for Postmarket Surveillance and Enforcement Public Workshop, September 12-13, 2011

July 21, 2011 5:31 am | by U.S. Food & Drug Administration | News | Comments

The Food and Drug Administration is holding a public workshop on the adoption, implementation, and use of unique device identifiers (UDIs) in various health-related electronic data systems. The purpose of this workshop is to engage multiple...

Information on Mobile Medical Applications

July 19, 2011 5:34 am | by U.S. Food & Drug Administration | News | Comments

Mobile applications are software programs that run on smartphones and other mobile communications devices. Development of mobile medical applications is opening new and innovative ways for technology to improve health and health care.

CardioGen-82 PET Scan: Drug Safety Communication - Increased Radiation Exposure

July 18, 2011 9:32 pm | by U.S. Food & Drug Administration | News | Comments

Potential for inadvertent, increased radiation exposure in patients who underwent or will be undergoing cardiac positron emission tomography (PET) scans

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AdvaMed: Device Spending Small Part of Health Expenses

July 15, 2011 2:30 pm | by U.S. Food & Drug Administration | News | Comments

Device spending and prices are not contributing to the rising cost of healthcare.

Medtronic & #8217;s Sales Could Suffer as InFuse Scandal Develops

July 15, 2011 2:30 pm | by U.S. Food & Drug Administration | News | Comments

Sales for Medtronic’s InFuse device are expected to plummet following more allegations that physicians guiding clinical trials covered up adverse events associated with the product.

Town Hall Discussion With the Director of CDRH and Other Senior Center Management, September 22, 2011

July 15, 2011 6:30 am | by U.S. Food & Drug Administration | News | Comments

In 2010, CDRH held three Town Hall meetings in Minneapolis, Boston, and Los Angeles to provide the public with a new venue to discuss issues of interest with the Center. Due to positive feedback, we planed three more this year. In March 2011, the...

Information on Urogynecologic Surgical Mesh Implants

July 14, 2011 6:31 am | by U.S. Food & Drug Administration | News | Comments

Surgical mesh is a medical device that is generally used to repair weakened or damaged tissue. It is made from porous absorbable or non-absorbable synthetic material or absorbable biologic material.

Draft Guidance for Industry and Food and Drug Administration Staff - In Vitro Companion Diagnostic Devices

July 12, 2011 9:31 am | by U.S. Food & Drug Administration | News | Comments

This guidance is intended to assist (1) sponsors who are planning to develop a therapeutic product that depends on the use of an in vitro companion diagnostic device (or test) for its safe and effective use and (2) sponsors planning to develop an in...

Tamiflu (oseltamivir phosphate) for Oral Suspension: Label Change-New Concentration (6 mg/mL)

July 11, 2011 7:30 am | by U.S. Food & Drug Administration | News | Comments

Patients may potentially receive either concentration (6 mg/mL or 12 mg/mL) from their pharmacy during the next influenza season (2011-2012).

Valproate Products: Drug Safety Communication - Risk of Impaired Cognitive Development in Children Exposed In Utero (During Pregnancy)

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

Benefits and risks of valproate sodium and related products should be carefully weighed when prescribing these drugs to women of childbearing age.

Endocet (Oxycodone / Acetaminophen) Tablets, ( 10mg, 325mg ) : Recall - Some Bottles Contain Different Strength Tablets

June 27, 2011 9:30 am | by U.S. Food & Drug Administration | News | Comments

Risk of increase of acetaminophen dose, which may result in liver toxicity, especially in patients on other acetaminophen containing medications.

Nature Relief Instant Wart and Mole Remover: Recall - Risk of Severe Skin Burns

June 27, 2011 9:30 am | by U.S. Food & Drug Administration | News | Comments

Active ingredient calcium oxide can cause severe burns, particularly to areas of thin or sensitive skin such as the face, around the eyes, and genitalia.

Butalbital, Acetaminophen, and Caffeine Tablets (USP 50mg, 325mg, 40mg) and Hydrocodone Bitartrate and Acetaminophen Tablets (USP 7.5mg, 500mg): Recall - Bottle Mislabeled

June 27, 2011 8:30 am | by U.S. Food & Drug Administration | News | Comments

Recalled bottles may contain incorrect tablets, patients may unintentionally take butalbital and caffeine instead of hydrocodone.

Erythropoiesis-Stimulating Agents (ESAs) In Chronic Kidney Disease: Drug Safety Communication - Modified Dosing Recommendations

June 24, 2011 8:31 am | by U.S. Food & Drug Administration | News | Comments

Increased risks of cardiovascular events using ESAs in this patient population.

Update on the Safety of Silicone Gel-Filled Breast Implants - Executive Summary

June 23, 2011 6:34 am | by U.S. Food & Drug Administration | News | Comments

Breast implants are medical devices that are used to augment breast size or to reconstruct the breast following mastectomy or to correct a congenital abnormality. Breast implants consist of a silicone outer shell and a filler (most commonly silicone gel..

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