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Public Workshop ? Magnetic Resonance Imaging Safety, October 25-26, 2011

September 20, 2011 7:30 am | by U.S. Food & Drug Administration | News | Comments

FDA is announcing a public workshop entitled: Magnetic Resonance Resonance Imaging (MRI) Safety Public Workshop. The purpose of the public workshop is to discuss factors affecting the safe use of magnetic resonance imaging MRI and approaches to mitigate

Boston Sci, Medtronic at Odds With IRS Over Transfer Tax

September 16, 2011 2:31 pm | by U.S. Food & Drug Administration | News | Comments

Devicemakers like Boston Scientific and Medtronic may be finding themselves caught in the gears of federal revenue raising as the IRS ramps up transfer pricing audits.

FDA: Do European Doctors Prefer FDA Approval Process to EC & #8217;s?

September 16, 2011 2:30 pm | by U.S. Food & Drug Administration | News | Comments

The FDA wants to know how heavily European physicians rely on clinical trial data used to get U.S. approval in decisions to prescribe devices, according to a request for proposals (RFP).

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Qualitest Pharmaceuticals Oral Contraceptives: Recall - Packaging Error

September 16, 2011 11:30 am | by U.S. Food & Drug Administration | News | Comments

Daily regimen may be incorrect and could leave women without adequate contraception.

H & P Industries Povidone Iodine Prep Pads: Recall - Potential Microbial Contamination

September 16, 2011 8:30 am | by U.S. Food & Drug Administration | News | Comments

UPDATED 09/16/2011. Lee Medical International Custom Dialysis Trays/Kits recalled. Use of contaminated Povidone Prep Pads could lead to life-threatening infections.

Class I Medical Device Recall: Lee Medical International Inc., Custom Dialysis Trays/Kits

September 16, 2011 7:30 am | by U.S. Food & Drug Administration | News | Comments

Reason for Recall: These custom dialysis trays/kits contain PVP Prep Pads that were recalled by H & P Industries. The pads may not be sterile. Patients receiving hemodialysis who use the pads may be at potential risk for serious or life threatening...

Zofran (ondansetron): Drug Safety Communication - Risk of Abnormal Heart Rhythms

September 15, 2011 11:30 am | by U.S. Food & Drug Administration | News | Comments

Avoid use of ondansetron in patients with congenital long QT syndrome, and monitor those with electrolyte abnormalities, CHF, bradyarrhythmias, or those taking concomitant medications that prolong the QT interval.

Medtronic Model 8637 SynchroMed II Implantable Infusion Pump: Class I Recall - Potential for Reduced Battery Performance

September 12, 2011 10:30 am | by U.S. Food & Drug Administration | News | Comments

Potential for reduced battery performance can lead to the sudden loss of therapy and the return of underlying symptoms and/or therapy withdrawal symptoms.

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Advisory Committee Notice of Meeting: October 13, 2011 - Circulatory System Devices Panel of the Medical Devices Advisory Committee

September 11, 2011 9:30 pm | by U.S. Food & Drug Administration | News | Comments

Confirmed Scheduled Advisory Meetings

Tax Will Drive Device Makers Overseas, AdvaMed Predicts

September 9, 2011 3:31 pm | by U.S. Food & Drug Administration | News | Comments

Devicemakers may flee overseas if the U.S. implements a recently enacted tax on prescription devices, AdvaMed says. The nation could lose thousands of device industry jobs and see demand shrink for products whose cost rises as a result of the excise tax, according to a report the trade...

CDRH Gets Slight Raise, Field Cut as Senate Budget Numbers Harden

September 9, 2011 3:30 pm | by U.S. Food & Drug Administration | News | Comments

FDA device regulators would get marginally more money in fiscal 2012 than in fiscal 2011, but nearly $7 million less than the agency sought.

Meeting Materials for the Obstetrics and Gynecology Devices Panel Meeting held on September 8-9, 2011

September 9, 2011 4:31 am | by U.S. Food & Drug Administration | News | Comments

The Obstetrics and Gynecology Devices Panel reviews and evaluates data concerning the safety and effectiveness of marketed and investigational in vitro devices for use in clinical laboratory medicine including clinical and molecular genetics...

Letter to Industry about Import Entry Review Process (September 6, 2011)

September 8, 2011 7:30 am | by U.S. Food & Drug Administration | News | Comments

The purpose of this follow up letter is to provide specific recommendations to facilitate the FDA import entry review process for medical and non-medical radiation-emitting electronic products.

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Tumor Necrosis Factor-alpha (TNF & alpha;) Blockers: Label Change - Boxed Warning Updated for Risk of Infection from Legionella and Listeria

September 7, 2011 10:30 am | by U.S. Food & Drug Administration | News | Comments

Patients treated with TNF? blockers are at increased risk for developing serious infections.

Safety Article: Take Precautions with Audible Alarms on Ventilators

September 6, 2011 11:30 am | by U.S. Food & Drug Administration | News | Comments

MECHANICAL ventilators provide essential respiratory support to critically ill patients in healthcare facilities, in homes, and during patient transport. Providing care to patients requiring mechanical ventilation can be challenging due to factors such...

PMAs for Silicone Implants Should Be Revoked, Consumers Tell FDA Panel

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

PMAs for silicone gel-filled breast implants should be revoked if manufacturers don’t improve post-approval study follow-up, consumer advocates and a former FDA official told an agency advisory panel.

User Fee Talks Near the Wire As FDA, Industry Butt Heads

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

Devicemakers and the FDA remain divided on the terms of Medical Device User Fee and Modernization Act (MDUFMA) reauthorization as the deadline approaches for resolving differences.

CDRH Learn (Spanish): Overview of Regulatory Requirements: Medical Devices - Video, slides, transcript

September 2, 2011 6:30 am | by U.S. Food & Drug Administration | News | Comments

Online training though video presentation, slide presentation on medical device regulatory requirements

Reclast (zoledronic acid): Drug Safety Communication - New Contraindication and Updated Warning on Kidney Impairment

September 1, 2011 12:31 pm | by U.S. Food & Drug Administration | News | Comments

Reclast should not be used in patients with creatinine clearance less than 35 mL/min or in patients with evidence of acute renal impairment.

Saphris (asenapine maleate): Drug Safety Communication: Serious Allergic Reactions

September 1, 2011 12:30 pm | by U.S. Food & Drug Administration | News | Comments

Reports of hypersensitivity reactions, including anaphylaxis (a life-threatening allergic reaction), angioedema, low blood pressure, rapid heart rate, swollen tongue, difficulty breathing, wheezing, or rash.

CDRH Learn (Spanish): 510(k) Third Party Review Online Video Presentation and Printable Slide Presentation

August 30, 2011 11:31 am | by U.S. Food & Drug Administration | News | Comments

510(k) Third Party Review Online Video Presentation and Printable Slide Presentation in Spanish

Industry Downplays Device Hacking Fears As GAO Mulls Investigation

August 26, 2011 1:31 pm | by U.S. Food & Drug Administration | News | Comments

Fears of hackers compromising implantable devices are unfounded, industry says.

High-Cost, High-Volume DME to See Competitive Federal Bidding

August 26, 2011 1:30 pm | by U.S. Food & Drug Administration | News | Comments

Competitive bidding will widen to the national stage for federal purchases of durable medical equipment (DME) and prosthetics, orthotics and supplies, the Centers for Medicare & Medicaid Services (CMS) said Friday.

Life-Threatening Injuries Associated with the ShoulderFlex Massager

August 25, 2011 3:31 pm | by U.S. Food & Drug Administration | News | Comments

The ShoulderFlex Massager, distributed by King International in Beaverton, OR, is a personal massage device designed for home use to provide deep tissue massage to the neck, shoulder and back while the user lies on a flat surface.

Celexa (citalopram hydrobromide): Drug Safety Communication - Abnormal Heart Rhythms Associated With High Doses

August 24, 2011 6:30 am | by U.S. Food & Drug Administration | News | Comments

Citalopram should no longer be prescribed at doses greater than 40 mg per day.

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