Regulatory
Abacavir - Ongoing Safety Review: Possible Increased Risk of Heart Attack
March 1, 2011 9:30 am | by U.S. Food & Drug Administration | News | CommentsFDA meta-analysis of clinical trials did not show an increased risk of MI associated with the use of abacavir.
Negative Pressure Wound Therapy (NPWT) systems - Preliminary Public Health Notification
February 28, 2011 3:30 am | by U.S. Food & Drug Administration | News | CommentsUPDATED 02/28/2011. Reports of deaths and serious complications, especially bleeding and infection, associated with NPWT.
Svelte 30: Recall - Undeclared Drug Ingredient
February 25, 2011 1:32 pm | by U.S. Food & Drug Administration | News | CommentsProduct marketed as a dietary supplement contains sibutramine, which may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.
EU Patent System Moves Forward But Still Facing Difficulties
February 25, 2011 1:32 pm | by U.S. Food & Drug Administration | News | CommentsWith the European Parliament’s consent for enhanced cooperation, a common EU patent system may become a reality.
Medtronic Is Cutting Staff, Selling Unit, in & #8216;Soft & #8217; Times
February 25, 2011 1:31 pm | by U.S. Food & Drug Administration | News | CommentsMedtronic is eliminating up to 2,000 positions during the third quarter as part of a major restructuring it blames on softer markets.
Consumer Information on: Revo MRI SureScan Pacing System - P090013
February 24, 2011 6:30 am | by U.S. Food & Drug Administration | News | CommentsThe Revo MRI SureScan Pacing System is designed to deliver standard pacing therapy in patients who have slow heart rates (bradycardia). Unlike most other pacing systems, the Revo MRI SureScan Pacing System has been specifically designed and tested to...
Summary Information for: Revo MRI SureScan Pacing System
February 24, 2011 6:30 am | by U.S. Food & Drug Administration | News | CommentsLabeling, Approval Order, and Summary of Safety and Effectiveness for Revo MRI SureScan Pacing System (P090013).
Extenze Tablets: Recall
February 23, 2011 10:31 am | by U.S. Food & Drug Administration | News | CommentsCounterfeit dietary supplement contains tadalafil, sildenafil, and/or sibutramine, which may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.
Medical Device Safety Tip: Infant Phototherapy Light
February 23, 2011 5:30 am | by U.S. Food & Drug Administration | News | CommentsFDA received a report about a brown area on the lens cover of an infant phototherapy light. Upon closer examination, the lens cover also had burned and melted areas from having been improperly positioned under the heating element of an infant warmer...
Antipsychotic drugs: Class Labeling Change - Treatment During Pregnancy and Potential Risk to Newborns
February 22, 2011 6:32 am | by U.S. Food & Drug Administration | News | CommentsRisk for abnormal muscle movements (extrapyramidal signs or EPS) and withdrawal symptoms in newborns whose mothers were treated with these drugs.
FDA Down-Classifies MDDS to Class I Via Final Rule
February 18, 2011 7:30 pm | by U.S. Food & Drug Administration | News | CommentsThe FDA has down-classified medical device data systems (MDDS) from Class III into Class I via a final rule, which could help manufacturers compete with IT companies in this area.
FDA Questions UK Regulator & #8217;s Data on Hip Implant Recalls(2)
February 18, 2011 5:31 pm | by U.S. Food & Drug Administration | News | CommentsQuality problems with metal-on-metal (MoM) hip replacement systems, like Johnson & Johnson (J&J)’s ASR devices, may not be as widespread as UK data indicates, the FDA says.
Terbutaline: Label Change - Warnings Against Use for Treatment of Preterm Labor
February 17, 2011 8:31 am | by U.S. Food & Drug Administration | News | CommentsPotential for serious maternal heart problems and death.
Medtronic SynchroMed II and SynchroMed EL Implantable Infusion Pump and Refill Kits: Class 1 Recall
February 16, 2011 1:31 pm | by U.S. Food & Drug Administration | News | CommentsRecall due to pocket fills may result in patient harm, serious injury, and/or death due to drug overdose or underdose.
Class I Medical Device Recall: Abbott Glucose Test Strips
February 15, 2011 6:30 am | by U.S. Food & Drug Administration | News | CommentsThese test strips may give falsely low glucose results. False results may lead patients or health care providers to try to raise their blood glucose unnecessarily, or they may fail to treat elevated blood glucose because of a false, low reading...
Class II Medical Device Recall: Triad Group, Triad Sterile Lubricating Jelly
February 15, 2011 4:30 am | by U.S. Food & Drug Administration | News | CommentsReason for Recall: This product may not be sterile. Patients, who are immuno-compromised, such as those with diabetes, cancer and certain other chronic diseases, may be at potential risk for infection.
FDA Finalizes Regulation for Certain Software, Hardware Used With Medical Devices
February 14, 2011 10:30 am | by U.S. Food & Drug Administration | News | CommentsToday, the FDA announced a final rule that provides a less-burdensome path to market for certain hardware and software products used with medical devices. The rule classifies these products, known as Medical Device Data Systems or MDDS, as Class I or...
Tra Warning Letter Cites Lack of GMP Procedures, Controls
February 11, 2011 2:31 pm | by U.S. Food & Drug Administration | News | CommentsAn FDA inspection of Tra & Accessories found failures in its control of design, purchasing and the warehouse environment for products, resulting in a warning letter.
Breast Implant Panel Requested, FDA Oversight Questioned
February 11, 2011 2:30 pm | by U.S. Food & Drug Administration | News | CommentsRep. Rosa DeLauro (D-Conn.) is “strongly urging” CDRH to hold an advisory committee meeting to release all available information on 10-year postmarket study results for saline breast implants and address issues with FDA oversight of the trials.
Information on Metal-on-Metal Hip Implants
February 10, 2011 10:30 am | by U.S. Food & Drug Administration | News | CommentsHip joint deterioration can lead to symptoms such as pain, stiffness or difficulty walking. When symptoms do not respond to conservative treatment, patients may be advised to undergo total hip replacement or hip resurfacing...
Arstasis One Access System: Class I Recall - Components May Fracture and/or Separate
February 9, 2011 9:30 am | by U.S. Food & Drug Administration | News | CommentsUse of recalled product may lead to patient harm.
Federal Register: Medical Device Innovation Initiative; Request for Comments
February 9, 2011 4:31 am | by U.S. Food & Drug Administration | News | CommentsThe report proposes potential actions for FDA's CDRH to facilitate the development, assessment, and regulatory review of innovative medical devices.
Federal Register: Medical Device Innovation Initiative; Public Meeting; Request for Comments
February 9, 2011 4:30 am | by U.S. Food & Drug Administration | News | CommentsFDA is seeking input on a number of identified challenges associated with incentivizing innovation, and the proposed solutions. In addition, the Agency requests comments on the Innovation Pathway proposed under the report.
Public Workshop - Center for Devices and Radiological Health's Innovation Initiative, March 15, 2011
February 8, 2011 4:31 am | by U.S. Food & Drug Administration | News | CommentsThe purpose of the public workshop is to solicit public feedback on select actions outlined in CDRH's Medical Device Innovation Initiative (report). FDA is seeking input on a number of identified challenges associated with incentivizing innovation, and...
CDRH Medical Device Innovation Initiative
February 8, 2011 4:30 am | by U.S. Food & Drug Administration | News | CommentsCDRH recognizes that transformative innovative devices typically present new scientific and regulatory challenges. The Innovation Initiative supports the development of innovative products by addressing some of the barriers that can impede a product's...
