Pradaxa (dabigatran etexilate mesylate): Drug Safety Communication - Safety Review of Post-Market Reports of Serious Bleeding EventsDecember 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.
CooperVision Avaira Aquaform Sphere Soft Contact Lenses: Class 1 Recall - Unintended Residue on LensesDecember 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.
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.
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 CommitteeDecember 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
The FDA has agreed to review its denial of sedation system Sedasys, prompting Johnson & Johnson subsidiary Ethicon Endo-Surgery to drop an appeal.
The FDA intends a new draft guidance on development of artificial pancreas device systems to be a map rather than a roadblock, an FDA official said in a Dec. 1 briefing.
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.
Washington, D.C. â€“ 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...
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.
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...
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.
Former executives of orthopedic devicemaker Synthes drew prison sentences for clinical trial rule violations that killed three people.
Monthly Safety Labeling Changes includes 48 products with revisions to Prescribing Information.
Labeling, Approval Order, and Summary of Safety and Effectiveness for NeuRx DPS?, Diaphragm Pacing System (H100006).
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...
Labeling, Approval Order, and Summary of Safety and Effectiveness for BELOTERO Balance (P090016).
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.
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.
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...
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...
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.