Regulatory
Federal Register: External Defibrillators; Public Workshop
November 16, 2010 8:31 am | by U.S. Food & Drug Administration | News | CommentsThe purpose of the public workshop is to share FDA's understanding of the risks and benefits of external defibrillators, to clarify FDA's current expectations for how industry should identify, report, and take action on problems observed with these...
Letter to Manufacturers of External Defibrillators About Developing Safer Products
November 15, 2010 4:31 am | by U.S. Food & Drug Administration | News | CommentsThe FDA is notifying you of our concerns relating to serious adverse events noted in Medical Device Reports (MDRs) associated with the use of external defibrillators and a large number of recalls of external defibrillators. As a result, FDA may, in the...
FDA Public Workshop on External Defibrillators, December 15-16, 2010(2)
November 15, 2010 4:31 am | by U.S. Food & Drug Administration | News | CommentsThe FDA is holding a public workshop to share FDA?s understanding of the risks and benefits of external defibrillators, to clarify FDA?s current expectations for how industry should identify, report, and take action on problems observed with these devices
Sigma Spectrum Infusion Pump Model 35700: Class 1 Recall: Risk of Over-Infusion
November 14, 2010 6:30 am | by U.S. Food & Drug Administration | News | CommentsUnit may fail suddenly, causing inaccurate flow,back flow,over-infusion, and free flow. Pump does not issue an alarm when this occurs and could result in serious injury or death.
Skin Closure System Reclassified, Special Controls Guidance Issued
November 12, 2010 4:32 pm | by U.S. Food & Drug Administration | News | CommentsClosure Medical may soon have more competition for its Prineo skin closure system now that the FDA has downgraded tissue adhesive with adjunct wound closure devices from Class III to Class II.
FDA, Health Canada to Pursue Joint Third-Party Inspections(2)
November 12, 2010 4:32 pm | by U.S. Food & Drug Administration | News | CommentsGiving devicemakers two inspections for the price of one, the FDA and Health Canada (HC) have agreed to move forward with a joint third-party inspection program.
Federal Register: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Medical Devices; Device Tracking
November 12, 2010 3:31 am | by U.S. Food & Drug Administration | News | CommentsThe Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish
VITEK 2 Gram Negative Susceptibility Cards Containing Piperacillin/Tazobactam (TZP): Recall - Incorrect Test Results Observed
November 10, 2010 6:30 am | by U.S. Food & Drug Administration | News | CommentsIncorrect results could potentially lead to patients being inappropriately treated with Piperacillin/Tazobactam, which could cause serious injury or death.
Federal Register: Medical Devices; General and Plastic Surgery Devices; Classification of Tissue Adhesive With Adjunct Wound Closure Device Intended for Topical Approximation ...
November 10, 2010 5:31 am | by U.S. Food & Drug Administration | News | CommentsThe FDA is classifying the tissue adhesive with adjunct wound closure device intended for topical approximation into class II (special controls).
Federal Register: Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Tissue Adhesive With Adjunct Wound Closure Device ...
November 10, 2010 5:30 am | by U.S. Food & Drug Administration | News | CommentsThis guidance document describes a means by which tissue adhesives with adjunct wound closure devices intended for the topical approximation of skin may comply with the requirement of special controls for class II devices.
Safety Investigation of CT Brain Perfusion Scans: Update 11/9/2010
November 9, 2010 4:31 am | by U.S. Food & Drug Administration | News | CommentsThe FDA is issuing this update to inform you of the findings of its investigation of the manufacturers of CT scanners that were the subject of the earlier communications as well as updated recommendations. In addition, this communication summarizes the...
Triton Pole Mount Infusion Pump by WalkMed: Recall - Potential Door Open Alarm Problem
November 8, 2010 5:30 am | by U.S. Food & Drug Administration | News | CommentsThe recalled pumps have been found to possibly have a problem with the pump door open alarm, which potentially could result in over infusion of medication.
CareFusion & #8217;s Antitrust Lawsuit Against Medtronic Is Dismissed
November 5, 2010 2:31 pm | by U.S. Food & Drug Administration | News | CommentsCareFusion failed to prove that Medtronic sought to illegally dominate the vertebroplasty and kyphoplasty markets, a federal district judge has ruled.
Roche, Stanford Patent Case Heads to US Supreme Court
November 5, 2010 2:31 pm | by U.S. Food & Drug Administration | News | CommentsA popular source for innovative new medical products could dry up, should the U.S. Supreme Court overturn a lower court’s ruling on a case involving Roche Molecular System and Stanford University.
Duro Extend Capsules for Men: Recall - Undeclared Drug Ingredient
November 5, 2010 9:30 am | by U.S. Food & Drug Administration | News | CommentsProduct marketed as dietary supplement contains undeclared Sulfoaidenafil, which may interact with nitrates found in some prescription drugs and lower blood pressure to dangerous levels.
Information on Security Screening of People
November 4, 2010 9:30 am | by U.S. Food & Drug Administration | News | CommentsPeople screening is the practice of searching people before allowing access to a secure area, for example at airports, court houses, prisons, or museums. People screening electronic products are used to detect concealed weapons, explosives or other...
Class I Medical Device Recall: Medtronic Octopus Nuvo Tissue Stabilizer, Model TSMICS1
November 2, 2010 10:30 am | by U.S. Food & Drug Administration | News | CommentsThis device stabilizes and minimizes the motion of selected areas of the beating heart during minimally invasive cardiac procedures while directly visualizing the heart through a small cut in the chest cavity.
Octopus Nuvo Tissue Stabilizer: Recall - Potential for Device Fracture(2)
November 1, 2010 5:31 pm | by U.S. Food & Drug Administration | News | CommentsFragments of the device could fall into the patient's chest cavity and damage the heart tissue.
CDRH Aiming to Toughen Stance On Use of Old Predicate Devices
October 30, 2010 1:31 pm | by U.S. Food & Drug Administration | News | CommentsAmid calls from devicemakers to improve its policies on predicate devices and promises from CDRH to do so, the center is beginning to clarify changes that may be in the works as part of its 510(k) overhaul.
Sen. Grassley Hunting for Link Between Medtronic, VA Adviser
October 30, 2010 1:31 pm | by U.S. Food & Drug Administration | News | CommentsIn another inquiry into devicemaker ties, Sen. Chuck Grassley (R-Iowa) is questioning the exact nature of the relationship between Medtronic and a former consultant, Stephen Ondra, who now serves as a senior policy adviser at the Department of Veterans Affairs (VA).
Heparin Sodium (B. Braun): Recall - Trace Contaminant
October 29, 2010 1:31 pm | by U.S. Food & Drug Administration | News | CommentsOversulfated chondroitin sulfate (OSCS) contaminant found during sample testing.
Federal Register: Mammography Quality Standards Act Requirements, 66104 [2010?27159]
October 27, 2010 5:31 am | by U.S. Food & Drug Administration | News | CommentsAgency Information Collection Activities; Announcement of Office of Management and Budget Approval; The Mammography Quality Standards Act Requirements
Federal Register: Draft Guidance, Emergency Use Authorization of Medical Products, 66104 [2010?27160]
October 27, 2010 5:30 am | by U.S. Food & Drug Administration | News | CommentsAgency Information Collection Activities; Announcement of Office of Management and Budget Approval; Draft Guidance, Emergency Use Authorization of Medical Products
Federal Register: Risk Communication Advisory Committee; Amendment of Notice
October 26, 2010 5:30 am | by U.S. Food & Drug Administration | News | CommentsOn November 8 and 9, 2010, the Committee will hear and discuss developments in FDA's ongoing communications programs, such as the challenges of effectively communicating with patients and caregivers about appropriate use of medical devices when...
GnRH Agonists: Label Change - Increased Risk of Diabetes and Cardiovascular Disease (Update)(2)
October 20, 2010 1:31 pm | by U.S. Food & Drug Administration | News | CommentsNew information warns about increased risk of diabetes and certain cardiovascular diseases (heart attack, sudden cardiac death, stroke) in men receiving these medications for the treatment of prostate cancer.
