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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...

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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

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The FDA intends a new draft guidance on development of artificial pancreas device systems to be a map rather than a roadblock, an FDA official said in a Dec. 1 briefing.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

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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.

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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).

Consumer Information on: Belotero Balance - P090016

November 22, 2011 8:31 am | by U.S. Food & Drug Administration | News | Comments

Belotero Balance is a transparent hyaluronic acid gel that is injected into facial tissue to smooth wrinkles and folds, especially around the nose and mouth. Hyaluronic acid is a protective, lubricating and binding gel that is produced naturally by the...

Summary Information for: BELOTERO Balance

November 22, 2011 8:31 am | by U.S. Food & Drug Administration | News | Comments

Labeling, Approval Order, and Summary of Safety and Effectiveness for BELOTERO Balance (P090016).

Harkin Hints 510(k) Doomsday Plan Might Be Revived Via User Fee Bill

November 18, 2011 1:32 pm | by U.S. Food & Drug Administration | News | Comments

Weeks after missing a self-imposed deadline to respond to Institute of Medicine (IOM) recommendations on the 510(k) process, CDRH Director Jeffrey Shuren told senators at a Tuesday hearing he’s unsure when the agency’s response will see daylight.

Industry Praises MDUFMA Progress, FDA Frets About Meeting Deadline

November 18, 2011 1:31 pm | by U.S. Food & Drug Administration | News | Comments

The device industry and the FDA are closer to an agreement on reauthorizing the Medical Device User Fee Amendments Act (MDUFMA), but chances are slim that the agency will meet the Jan. 15 goal to delivery that agreement to Congress.

Minutes From Negotiation Meeting on MDUFA III Reauthorization, September 13, 2011

November 18, 2011 4:31 am | by U.S. Food & Drug Administration | News | Comments

Industry provided a response and counter-proposal to the proposal offered by the Agency on August 24, 2011. Industry reiterated that their intent from the beginning of these negotiations has been to achieve a process that is efficient and ultimately...

Carestream Receives FDA Clearance Letter for Mobile Use of Its Vue Motion Medical Image Viewer

November 16, 2011 5:18 am | News | Comments

ROCHESTER, N.Y.--(BUSINESS WIRE)--Carestream has received a clearance letter from the U.S. Food and Drug Administration (FDA) for the use of its Vue Motion medical image viewer with mobile devices such as Apple iPads in the United States. The zero-footprint, Web-based viewer...

MedPro Safety Products Receives ISO 13485 Recertification

November 15, 2011 5:35 am | News | Comments

LEXINGTON, Ky.--(BUSINESS WIRE)--MedPro Safety Products, Inc. (OTCBB: MPSP), a leading developer of transformational technologies that enable safer medication delivery and blood collection, today announced that it has passed its ISO 13485 recertification audit.

Positive Clinical Study Results for BSP's HyperQ Technology will be reported in American Journal of Cardiology

November 15, 2011 4:56 am | News | Comments

Tel - Aviv, November 14, 2011 - BSP Biological Signal Processing Ltd. (BSP) (TASE: BSP), which develops and manufactures products for the non-invasive, accurate diagnosis of Coronary Artery Disease (CAD), recently announced the successful completion of a comprehensive clinical research study...

Over 100,000 People Urge the FDA to Issue Clear and Reasonable Guidance on the Artificial Pancreas

November 15, 2011 4:52 am | News | Comments

Washington, D.C. – Over 100,000 people throughout the country have signed a petition urging the FDA to issue clear and reasonable guidance  for development of an artificial pancreas (AP), the most revolutionary advance in treating type 1 diabetes (T1D) since the discovery of insulin.

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