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Draft Guidance for Industry and FDA Staff- Humanitarian Use Device (HUD) Designations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

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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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CooperVision Avaira Aquaform Sphere Soft Contact Lenses: Class 1 Recall - Unintended Residue on Lenses

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

Symptoms may range from hazy, blurry vision, discomfort to eye injuries requiring medical treatment.

Video: LASIK Surgery and its Risks

December 7, 2011 5:31 am | by U.S. Food & Drug Administration | News | Comments

LASIK is a surgical procedure intended to reduce a person's dependency on glasses or contact lenses. The goal of this Web site is to provide objective information to the public about LASIK surgery.

Class I Medical Device Recall: CooperVision AVAIRA AQUAFORM Sphere Soft Contact Lenses

December 7, 2011 5:30 am | by U.S. Food & Drug Administration | News | Comments

Reason for Recall: The unintended presence of a silicone oil residue on AVAIRA Sphere soft contact lenses. Symptoms may range from hazy, blurry vision, discomfort to eye injuries requiring medical treatment.

Class I Medical Device Recall: Draeger Medical Inc., Infinity Acute Care System Monitoring Solution (M540)

December 6, 2011 4:30 am | by U.S. Food & Drug Administration | News | Comments

The weight-based drug dosage calculation may indicate incorrect recommended values, including a drug dosage up to ten times the indicated dosage. Additionally, there may be a 5-10 second delay between the electrocardiogram and blood pressure curves...

Meeting Materials for December 7-8, 2011 Circulatory System Devices Panel of the Medical Devices Advisory Committee

December 5, 2011 5:30 am | by U.S. Food & Drug Administration | News | Comments

Meeting Materials for December 7-8, 2011 Circulatory System Devices Panel of the Medical Devices Advisory Committee

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Ethicon Drops Sedasys PMA Appeal As FDA Agrees to & #8220;Expeditious & #8221; Review

December 2, 2011 1:31 pm | by U.S. Food & Drug Administration | News | Comments

The FDA has agreed to review its denial of sedation system Sedasys, prompting Johnson & Johnson subsidiary Ethicon Endo-Surgery to drop an appeal.

FDA Hopes Artificial Pancreas Guidance is Flexible, Encouraging

December 2, 2011 1:31 pm | by U.S. Food & Drug Administration | News | Comments

The FDA intends a new draft guidance on development of artificial pancreas device systems to be a map rather than a roadblock, an FDA official said in a Dec. 1 briefing.

Premarket Approval (PMA) Summary Review Memos for 180-Day Design Changes (New Memos Available)

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

As a pilot program under the CDRH Transparency Initiative, FDA has begun releasing some summary review memos for 180-day PMA supplements relating to design changes. Links to all available summary review memos can be found here.

JDRF Encouraged By Draft FDA Artificial Pancreas Guidance

December 2, 2011 4:24 am | News | Comments

Washington, D.C. – The JDRF today said it is encouraged that the Food and Drug Administration (FDA) has issued a draft guidance which appears to lay a foundation for accelerating the development and availability of artificial pancreas technology (AP) that will improve the lives of millions...

Draft Guidance for Industry and Food and Drug Administration Staff - The Content of Investigational Device Exemption (IDE) and Premarket Applications for Artificial Pancreas D...

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

This draft guidance is intended to provide recommendations to Sponsors or Applicants planning to develop and submit an Investigational Device Exemption (IDE) or premarket approval (PMA) application for an Artificial Pancreas Device System (APDS) for...

Updated Information on Artificial Pancreas Systems

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

The FDA is helping advance the development of an artificial pancreas system -- an innovative device that automatically monitors blood glucose and provides appropriate insulin doses in people with type 1 diabetes.

PMA Final Decisions for October 2011

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

These are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions for October 2011.

Guidance for Industry and Food and Drug Administration Staff - Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and D...

November 28, 2011 3:31 am | by U.S. Food & Drug Administration | News | Comments

FDA is issuing this guidance to provide industry and agency staff with recommendations for studies to establish the performance characteristics of in vitro diagnostic devices (IVDs) intended for the detection, or detection and differentiation, of human...

Asia-Pacific Cooperation Forum Aims for Device Harmonization by 2020

November 25, 2011 2:32 pm | by U.S. Food & Drug Administration | News | Comments

The Asia-Pacific Economic Cooperation (APEC) forum has agreed on a strategic plan to align regulatory approval procedures for medicines and medical devices by the end of the decade.

Ex-Synthes Execs Prison-Bound for Deaths in Unauthorized Trials

November 25, 2011 2:31 pm | by U.S. Food & Drug Administration | News | Comments

Former executives of orthopedic devicemaker Synthes drew prison sentences for clinical trial rule violations that killed three people.

October 2011

November 25, 2011 1:31 pm | by U.S. Food & Drug Administration | News | Comments

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

Summary Information for: NeuRx DPS?, Diaphragm Pacing System

November 23, 2011 4:30 am | by U.S. Food & Drug Administration | News | Comments

Labeling, Approval Order, and Summary of Safety and Effectiveness for NeuRx DPS?, Diaphragm Pacing System (H100006).

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