Regulatory
MDUFA Language Published, Public Meeting Set for March 28
March 16, 2012 2:31 pm | by U.S. Food & Drug Administration | News | CommentsThe FDA expects to collect $595 million in device user fees by fiscal 2017, according to the FDA’s outline for the reauthorization of the Medical Device User Fee Act (MDUFA).
Guidance for Industry, Third Parties and Food and Drug Administration Staff - Medical Device ISO 13485:2003 Voluntary Audit Report Submission Pilot Program
March 16, 2012 5:31 am | by U.S. Food & Drug Administration | News | CommentsThis guidance provides information on the implementation of section 228 of the Food and Drug Administration Amendments Act of 2007 (FDAAA), Public Law 110-85, which amended section 704(g)(7) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act)...
Draft Guidance for Industry and Food and Drug Administration Staff - Class II Special Controls Guidance Document: Nucleic Acid-Based In Vitro Diagnostic Devices for the Detect...
March 16, 2012 5:30 am | by U.S. Food & Drug Administration | News | CommentsThis document was developed to support the reclassification of nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex (MTB-complex) in respiratory specimens from class III into class II. These devices are...
Skin Creams, Soaps and Lotions Marketed as Skin Lighteners and Anti-aging Treatments: May Contain the Toxic Metal, Mercury
March 15, 2012 1:31 pm | by U.S. Food & Drug Administration | News | CommentsProducts with this toxic metal have been found in at least seven states, are manufactured abroad and often sold in shops in Latino, Asian, African or Middle Eastern neighborhoods and online.
Public Workshop - Medical Device User Fee Program Public Meeting, March 28, 2012
March 15, 2012 9:31 am | by U.S. Food & Drug Administration | News | CommentsThe purpose of the meeting is to provide an opportunity for stakeholders to present their views on the draft recommendations for the reauthorization of the medical device user fee program. We welcome this opportunity to hear from stakeholders as we...
Minutes from Stakeholder Meeting on MDUFA III Reauthorization, February 28, 2012
March 15, 2012 9:31 am | by U.S. Food & Drug Administration | News | CommentsFDA reported that they have concluded negotiations with Industry. On February 17, 2012 they reached agreement with all four industry associations Industry on the final details of the fee structure and minor changes to the draft Commitment Letter and...
Consumer Information on: EverFlex Self-Expanding Peripheral Stent System - P110023
March 14, 2012 7:31 am | by U.S. Food & Drug Administration | News | CommentsThe EverFlex Self-Expanding Peripheral Stent System is used to re-open narrowed (stenotic) regions of the superficial femoral and proximal popliteal arteries which supply blood to the legs. It consists of two components, the stent and the delivery...
Summary Information for: EverFlex Self-Expanding Peripheral Stent System
March 14, 2012 7:31 am | by U.S. Food & Drug Administration | News | CommentsLabeling, Approval Order, and Summary of Safety and Effectiveness for EverFlex Self-Expanding Peripheral Stent System (P110023).
PMA Final Decisions for January 2012
March 13, 2012 1:31 pm | by U.S. Food & Drug Administration | News | CommentsThese are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions for January 2012.
Class I Medical Device Recall: Acclarent Inspira AIR Balloon Dilation System, size 18X40mm.
March 13, 2012 1:31 pm | by U.S. Food & Drug Administration | News | CommentsReason for Recall: Acclarent identified the potential for the balloon to not deflate or to deflate slowly, which could result in airway obstruction until the balloon is deflated or removed. Prolonged obstruction of the airway may prevent adequate blood...
Acclarent Inspira AIR Balloon Dilation System: Class 1 Recall - Potential For Balloon To Not Deflate Or To Deflate To Slowly
March 13, 2012 1:31 pm | by U.S. Food & Drug Administration | News | CommentsProlonged obstruction of the airway may prevent adequate blood oxygenation, which could cause temporary or permanent impairment to the patient
Synthes Slapped With Wrongful Deaths Suit, FDA Warning Letter
March 9, 2012 1:31 pm | by U.S. Food & Drug Administration | News | CommentsSwiss devicemaker Synthes faces trouble from two sides, with an FDA warning letter posted just days after the company was sued by the families of two patients who died on the operating table during illegal clinical trials.
OIG Finds No Basis to Prosecute & #8216;FDA Nine & #8217; Over Personal Emails
March 9, 2012 1:31 pm | by U.S. Food & Drug Administration | News | CommentsAfter consulting with Justice Department prosecutors, the HHS Office of Inspector General (OIG) has found nothing to substantiate the FDA’s claim that it began monitoring nine employees’ emails only after hearing that confidential industry information had been leaked to the...
Gerber Good Start Gentle Powdered Infant Formula: Recall - Off-Odor
March 9, 2012 8:30 am | by U.S. Food & Drug Administration | News | CommentsReports of gastrointestinal complaints.
Guidance for Industry and Food and Drug Administration Staff - Class II Special Controls Guidance Document: Norovirus Serological Reagents
March 8, 2012 5:30 am | by U.S. Food & Drug Administration | News | CommentsThis special controls guidance document was developed to support the classification into class II (special controls) of norovirus serological reagents. These devices detect norovirus antigens in human fecal specimens as an aid in the diagnosis of...
Summary Information for: ION? Paclitaxel-Eluting Coronary Stent System (Monorail and Over-the-Wire Delivery Systems)
March 7, 2012 6:30 am | by U.S. Food & Drug Administration | News | CommentsLabeling, Approval Order, and Summary of Safety and Effectiveness for ION? Paclitaxel-Eluting Coronary Stent System (Monorail and Over-the-Wire Delivery Systems) (P100023S015).
Summary Information for: Resolute MicroTrac Zotarolimus-Eluting Coronary Stent System (Resolute MicroTrac) and Resolute Integrity Zotarolimus-Eluting Coronary Stent System (Re...
March 7, 2012 4:30 am | by U.S. Food & Drug Administration | News | CommentsLabeling, Approval Order, and Summary of Safety and Effectiveness for Resolute MicroTrac Zotarolimus-Eluting Coronary Stent System (Resolute MicroTrac) and Resolute Integrity Zotarolimus-Eluting Coronary Stent System (Resolute Integrity) (P110013).
Consumer Information on: Breast Companion & #xae; Software System - P100007
March 6, 2012 7:32 am | by U.S. Food & Drug Administration | News | CommentsThe Breast Companion® Software System is a computer-aided report-generating system intended to improve the ACR BI-RADS® (American College of Radiology, Breast Imaging Reporting and Data System) assessment of ultrasound images of lesions of the...
Summary Information for: Breast Companion & #xae; Software System
March 6, 2012 7:32 am | by U.S. Food & Drug Administration | News | CommentsLabeling, Approval Order, and Summary of Safety and Effectiveness for Breast Companion® Software System (P100007).
Houston Medical Robotics, Inc. Receives FDA 510(k) Clearance for Euclid Tier 1 Mini Access System
March 6, 2012 4:48 am | News | CommentsHouston Medical Robotics, Inc. announces that it has received U.S. Food and Drug Administration 510(k) clearance to market the Euclidâ„¢ Tier 1 Mini Access System. The Euclidâ„¢ Tier 1 Mini Access System is a portable, hand-held device that integrates commercially available...
Summary Information for: Ovation Abdominal Stent Graft System
March 5, 2012 5:31 am | by U.S. Food & Drug Administration | News | CommentsLabeling, Approval Order, and Summary of Safety and Effectiveness for Ovation Abdominal Stent Graft System (H100008).
Consumer Information on: OVATION Abdominal Stent Graft System - H100008
March 5, 2012 5:31 am | by U.S. Food & Drug Administration | News | CommentsThe OVATION abdominal stent graft system is used to treat abdominal aortic aneurysms during endovascular repair (EVAR). An aneurysm is a diseased, bulging, weak section of an artery wall; in this case the aorta. The main portion of the OVATION abdominal..
Cardiac Science Powerheart, CardioVive, CardioLife; GE Responder and Responder Pro; and Nihon-Kohden Automated External Defibrillators (AEDs): Class I Recall - Defective Compo...
March 2, 2012 2:31 pm | by U.S. Food & Drug Administration | News | CommentsUnexpected component failure may lead to AEDs not delivering defibrillation therapy, causing serious adverse health consequences, including death.
Class I Medical Device Recall: Cardiac Science Powerheart, CardioVive, CardioLife; GE Responder and Responder Pro; and Nihon-Kohden Automated External Defibrillators - AEDs
March 2, 2012 7:30 am | by U.S. Food & Drug Administration | News | CommentsThe affected AEDs contain a component that may fail unexpectedly due to a defect. If the component were to fail during a rescue attempt, the AED may not deliver defibrillation therapy causing serious adverse health consequences
Statins and HIV or Hepatitis C Drugs: Drug Safety Communication - Interaction Increases Risk of Muscle Injury
March 1, 2012 11:30 am | by U.S. Food & Drug Administration | News | CommentsProtease inhibitors and statins taken together may raise the blood levels of statins and increase the risk of myopathy, kidney damage, and kidney failure, which can be fatal.
