Items added to the FDA's Center for Devices and Radiological Health website within the last month. http://www.fda.gov/cdrh/newpg.html en-us Sat, 07 Nov 2009 05:19:22 GMT webo@cdrh.fda.gov http://www.fda.gov/cdrh/images/homepg/c-d-r-h.gif http://www.fda.gov/cdrh/ FDA is issuing this guidance to inform industry and agency staff of its recommendations for the type of information and data FDA believes needs to be included in an Emergency Use Authorization Request (EUA) for in vitro diagnostic (IVD) devices intended.. Fri, 06 Nov 2009 05:00:00 GMT http://edocket.access.gpo.gov/2009/E9-26737.htm Reason for Recall: Laboratories are unable to recover patient samples above 200mg/dL that results in inaccurate glucose values above this range. Fri, 06 Nov 2009 05:00:00 GMT http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm189467.htm Thu, 05 Nov 2009 05:00:00 GMT http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/510kClearances/ucm189265.htm The October 2008 Memorandum of Understanding between the FDA and WebMD will continue as written for five years from the date of the signature by the latter Party to sign the October 2009 Addendum to the Memorandum between the FDA and WebMD, L.L.C., whereu Thu, 05 Nov 2009 05:00:00 GMT http://edocket.access.gpo.gov/2009/E9-26674.htm FDA is investigating energy levels in external biphasic defibrillators with shocks = 200 J. We have received reports of 14 events since 2006 in which a 200 J biphasic defibrillator was ineffective in providing defibrillation/cardioversion therapy to a... Thu, 05 Nov 2009 05:00:00 GMT http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm189259.htm This document provides guidance on the type of information and data that FDA recommends you include in an Emergency Use Authorization (EUA) request for in vitro diagnostic (IVD) devices intended for use in diagnosing 2009 H1N1 Influenza virus infections.. Thu, 05 Nov 2009 05:00:00 GMT The VIDAS fPSA rt Assay is a lab tests, used along with digital rectal examination, to help diagnose prostate cancer in men age 50 years and older. Thu, 05 Nov 2009 05:00:00 GMT http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm189301.htm Labeling, Approval Order, and Summary of Safety and Effectiveness for VIDAS free PSA rt (fPSA) Assay (P080008). Thu, 05 Nov 2009 05:00:00 GMT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/pma/pma.cfm?num=P080008 Reason for Recall: The manufacturer of the pediatric tracheal tubes used in these kits recalled them because they were manufactured with an internal diameter smaller than indicated on the label, which could result in an inability to remove secretions... Wed, 04 Nov 2009 05:00:00 GMT http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm188972.htm FDA wants to remind you that cybersecurity for medical devices and their associated communication networks is a shared responsibility between medical device manufacturers and medical device user facilities. Wed, 04 Nov 2009 05:00:00 GMT http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm189111.htm Reason for Recall: A potential malfunction may cause serious injury or death. Tue, 03 Nov 2009 05:00:00 GMT http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm188795.htm On December 18, 2009, the committee will discuss, make recommendations, and vote on a premarket approval application, sponsored by Envoy Medical Corporation, for the Esteem Totally Implantable Hearing System. Mon, 02 Nov 2009 05:00:00 GMT http://edocket.access.gpo.gov/2009/E9-26260.htm On December 11, 2009, the committee will discuss and make recommendations on the study designs and endpoints of clinical investigations intended to support approval or clearance of devices indicated for the primary treatment of localized prostate cancer. Mon, 02 Nov 2009 05:00:00 GMT http://edocket.access.gpo.gov/2009/E9-26259.htm The postponement of the November 20, 2009 meeting is due to a scheduling conflict. A future meeting date will be announced in the Federal Register. Mon, 02 Nov 2009 05:00:00 GMT http://edocket.access.gpo.gov/2009/E9-26261.htm These are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions for September 2009. Tue, 27 Oct 2009 04:00:00 GMT http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/PMAApprovals/ucm188127.htm The FDA is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Thu, 22 Oct 2009 04:00:00 GMT http://edocket.access.gpo.gov/2009/E9-25395.htm The committee will discuss and make recommendations regarding the agency's regulatory strategy for Full Field Digital Mammography (FFDM) Devices. Thu, 22 Oct 2009 04:00:00 GMT http://edocket.access.gpo.gov/2009/E9-25406.htm These draft guidances provides recommendations regarding premarket notification (510(k)) submissions of certain computer-assisted detection (CADe) devices applied to radiology images and radiology device data and recommendations on how to design and... Wed, 21 Oct 2009 04:00:00 GMT http://edocket.access.gpo.gov/2009/E9-25233.htm This guidance document describes a means by which cardiac allograft gene expression profiling test systems may comply with the requirement of special controls for class II devices. It includes recommendations for validation of performance... Wed, 21 Oct 2009 04:00:00 GMT http://edocket.access.gpo.gov/2009/E9-25313.htm The device is assigned the generic name 'Cardiac allograft gene expression profiling test system.' It is identified as a device that measures the RNA expression level of multiple genes and combines this information to yield a signature... Wed, 21 Oct 2009 04:00:00 GMT http://edocket.access.gpo.gov/2009/E9-25315.htm The Food and Drug Administration (FDA) has launched a new Web site that will benefit current and potential users of hearing aids. Tue, 20 Oct 2009 04:00:00 GMT http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm185723.htm FDA's investigational device regulations are intended to encourage the development of new, useful devices in a manner that is consistent with public health, safety, and with ethical standards. Investigators should have freedom to pursue the least... Tue, 20 Oct 2009 04:00:00 GMT http://edocket.access.gpo.gov/2009/E9-25178.htm Congress passed CLIA (Public Law 100-578) in 1988 to establish quality standards for all laboratory testing. The purpose was to ensure the accuracy, reliability, and timeliness of patient test results regardless of where the test took place... Tue, 20 Oct 2009 04:00:00 GMT http://edocket.access.gpo.gov/2009/E9-25177.htm This draft guidance document provides recommendations to industry, systems and service providers, consultants, FDA staff, and others regarding clinical performance assessment of computer-assisted detection (CADe) devices applied to radiology images and... Tue, 20 Oct 2009 04:00:00 GMT This draft guidance document provides recommendations to industry, systems and service providers, consultants, FDA staff, and others regarding premarket notification (510(k)) submissions for computer-assisted detection (CADe) devices applied to... Tue, 20 Oct 2009 04:00:00 GMT This guidance document was developed as a special controls guidance to support the classification of cardiac allograft gene expression profiling test systems into class II (special controls). A cardiac allograft gene expression profiling test system is... Tue, 20 Oct 2009 04:00:00 GMT You've likely seen them advertised on television?small electronic sound amplifiers that allow users to enjoy nighttime TV without disturbing sleepers, or to hear their toddlers from many yards away... Tue, 20 Oct 2009 04:00:00 GMT http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm185459.htm Having trouble hearing? Over 35 million children and adults in the United States have some degree of hearing loss. Hearing loss can have a negative effect on communication, relationships, school/work performance, and emotional well-being... Tue, 20 Oct 2009 04:00:00 GMT http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/HomeHealthandConsumer/ConsumerProducts/HearingAids/default.htm The FDA is announcing the Web location where it will post a list of guidance documents CDRH is considering for development. In addition, FDA has established a docket where stakeholders may provide comments and/or draft language for those topics as well as Tue, 20 Oct 2009 04:00:00 GMT http://edocket.access.gpo.gov/2009/E9-25179.htm FDA is investigating whether certain types of power cords used with medical devices may be defective. Mon, 19 Oct 2009 04:00:00 GMT http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm187078.htm The FDA is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Fri, 16 Oct 2009 04:00:00 GMT http://edocket.access.gpo.gov/2009/E9-24921.htm This guidance document describes a means by which wound dressing with Poly (diallyl dimethyl ammonium chloride) (pDADMAC) additive may comply with the requirement of special controls for class II devices. Fri, 16 Oct 2009 04:00:00 GMT http://edocket.access.gpo.gov/2009/E9-24964.htm The FDA is publishing a list of premarket approval applications (PMAs) that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the agency's... Fri, 16 Oct 2009 04:00:00 GMT http://edocket.access.gpo.gov/2009/E9-24967.htm The Food and Drug Administration (FDA) is classifying the wound dressing with pDADMAC additive into class II (special controls). Fri, 16 Oct 2009 04:00:00 GMT http://edocket.access.gpo.gov/2009/E9-24963.htm The FDA is postponing the meeting of the NMQA Advisory Committee scheduled for November 2, 2009. The postponement is due to guidance documents planned for discussion at the meeting are not yet available. Fri, 16 Oct 2009 04:00:00 GMT http://edocket.access.gpo.gov/2009/E9-24895.htm Nominations will be accepted for current vacancies and those that will or may occur through August 31, 2010. Fri, 16 Oct 2009 04:00:00 GMT http://edocket.access.gpo.gov/2009/E9-24896.htm On November 20, 2009, the committee will discuss, make recommendations and vote on a premarket approval application for the Deep Brain Stimulation System for Epilepsy sponsored by Medtronic, Inc. Fri, 16 Oct 2009 04:00:00 GMT http://edocket.access.gpo.gov/2009/E9-24893.htm The purpose of the public workshop is to provide an opportunity to share information and perspectives with health care providers, academia, and industry on various aspects of diagnostic test development for respiratory infections. Thu, 15 Oct 2009 04:00:00 GMT http://edocket.access.gpo.gov/2009/E9-24828.htm The FDA is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Thu, 15 Oct 2009 04:00:00 GMT http://edocket.access.gpo.gov/2009/E9-24825.htm This guidance document was developed as a special control guidance to support the classification of the wound dressing with Poly(diallyl dimethyl ammonium chloride) (pDADMAC) additive into class II (special controls). Thu, 15 Oct 2009 04:00:00 GMT The FDA is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Tue, 13 Oct 2009 04:00:00 GMT http://edocket.access.gpo.gov/2009/E9-24544.htm This document is intended to provide guidance to mammography facilities and their personnel. It represents FDA's current thinking on the final regulations implementing the Mammography Quality Standards Act of 1992 (MQSA). Fri, 09 Oct 2009 04:00:00 GMT http://edocket.access.gpo.gov/2009/E9-24435.htm Draft Guidance for Industry, MQSA Inspectors and FDA Staff - The Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System #13 Fri, 09 Oct 2009 04:00:00 GMT This guidance document was developed as a special controls guidance to support the classification of respiratory viral panel multiplex nucleic acid assays into class II (special controls). Fri, 09 Oct 2009 04:00:00 GMT This document was developed as a special control to support the classification into class II (special controls) of respiratory viral panel multiplex nucleic acid assays that include detection and differentiation of Influenza A virus subtypes. Fri, 09 Oct 2009 04:00:00 GMT This document was developed as a special controls guidance to support the classification into class II (special controls) of a respiratory viral panel multiplex nucleic acid assay that includes detection and identification of human metapneumovirus (hMPV). Fri, 09 Oct 2009 04:00:00 GMT These guidance documents describe a means by which respiratory viral panel multiplex nucleic acid assays may comply with the requirement of special controls for class II devices. Fri, 09 Oct 2009 04:00:00 GMT http://edocket.access.gpo.gov/2009/E9-24431.htm The Food and Drug Administration (FDA) is announcing the classification of the respiratory viral panel multiplex nucleic acid assay into class II (special controls). Fri, 09 Oct 2009 04:00:00 GMT http://edocket.access.gpo.gov/2009/E9-24432.htm The purpose of this guidance is to explain recent changes in the device registration and listing program to owner/operators and official correspondents of device establishments and to help them fulfill these new requirements. Thu, 08 Oct 2009 04:00:00 GMT The purpose of this guidance is to explain recent changes in the device registration and listing program to owner/operators and official correspondents of device establishments and to help them fulfill these new requirements. Thu, 08 Oct 2009 04:00:00 GMT http://edocket.access.gpo.gov/2009/E9-24349.htm FDA has become aware of radiation overexposures during perfusion CT imaging to aid in the diagnosis and treatment of stroke. Thu, 08 Oct 2009 04:00:00 GMT http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm185898.htm