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Concerns about the future of the FDA’s 510(k) process appear to have been put to rest with the year-end issuance of a draft guidance on evaluating substantial equivalence in 510(k)s.

Draft Guidance for Industry and Food and Drug Administration Staff - Medical Device Classification Product Codes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

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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...

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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.

Draft Guidance for Industry and Food and Drug Administration Staff - Evaluation of Sex Differences in Medical Device Clinical Studies

December 16, 2011 4:31 am | by U.S. Food & Drug Administration | News | Comments

The purpose of this guidance is to outline the Center for Devices and Radiological Health?s (CDRH) expectations regarding sex-specific patient enrollment, data analysis, and reporting of study information. The intent is to improve the quality and...

Selective Serotonin Reuptake Inhibitor (SSRI) Antidepressants: Drug Safety Communication - Use During Pregnancy and Potential Risk of Persistent Pulmonary Hypertension of the...

December 14, 2011 11:31 am | by U.S. Food & Drug Administration | News | Comments

Conflicting results from different studies makes it premature to reach any conclusion about a possible link between SSRI use in pregnancy and PPHN.

November 2011

December 14, 2011 4:30 am | by U.S. Food & Drug Administration | News | Comments

Monthly Safety Labeling Changes includes 48 products with revisions to Prescribing Information.

Draft Guidance for Industry and FDA Staff- Humanitarian Use Device (HUD) Designations

December 13, 2011 9:31 am | by U.S. Food & Drug Administration | News | Comments

This guidance document is intended to assist applicants in the preparation and submission of Humanitarian Use Device (HUD) designation request to the U.S. Food and Drug Administration (FDA or Agency) Office of Orphan Products Development (OOPD). It is...

- Products and Medical Procedures Implants and Prosthetics Current Page is:Gastric Banding - Gastric Banding

December 13, 2011 7:31 am | by U.S. Food & Drug Administration | News | Comments

Gastric banding is a surgical procedure to reduce the size of the stomach for weight loss. In this procedure, a silicone band is placed around the upper portion of the stomach to create a small pouch.

Law Expert Says High Court Likely to Favor Prometheus Test Patent

December 9, 2011 1:31 pm | by U.S. Food & Drug Administration | News | Comments

The U.S. Supreme Court appears unconvinced after oral arguments on Prometheus Laboratories’ thiopurine metabolites test patent, but one legal expert predicts the high court will uphold an appeals court decision in favor of Prometheus.

FDA Considers More Registries, Virtual Research for Devices

December 9, 2011 1:31 pm | by U.S. Food & Drug Administration | News | Comments

For some devices, laboratory testing and computer modeling may work better than clinical trials, William Maisel, deputy center director of CDRH, said.

Invacare Corporation Announces Discussions with The FDA

December 9, 2011 5:48 am | News | Comments

ELYRIA, Ohio--(BUSINESS WIRE)--Invacare Corporation today announced that the U.S. Food and Drug Administration (FDA) has requested that the Company negotiate and agree to a consent decree of injunction relating to previously disclosed inspectional observations...

LifeScience Alley and FDA's Devices Center Sign Memorandum of Understanding to Advance Regulatory Science

December 9, 2011 5:33 am | News | Comments

MINNEAPOLIS--(BUSINESS WIRE)--LifeScience Alley announced today that it has signed a memorandum of understanding (MOU) with the U.S. Food and Drug Administration's Center for Devices and Radiological Health (CDRH). The MOU formalizes interactions that have been occurring

Pradaxa (dabigatran etexilate mesylate): Drug Safety Communication - Safety Review of Post-Market Reports of Serious Bleeding Events

December 7, 2011 8:31 am | by U.S. Food & Drug Administration | News | Comments

Bleeding that may lead to serious or even fatal outcomes is a well-recognized complication of all anticoagulant therapies. FDA is working to determine whether reports of bleeding are occurring more commonly than would be expected.

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