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 Fri, 16 May 2008 12:46:46 GMT webo@cdrh.fda.gov http://www.fda.gov/cdrh/images/homepg/c-d-r-h.gif http://www.fda.gov/cdrh/newpg.html This compliance program provides guidance to FDA field and center staff for the inspection, field test and administrative/enforcement activities related to the Electronic Product Radiation Control (EPRC) provisions of the Federal Food Drug and Cosmetic... Thu, 15 May 2008 04:00:00 GMT http://www.fda.gov/cdrh/ocer/guidance/7386.003a.html http://www.fda.gov/cdrh/ocer/guidance/7386.003a.html On March 4 and 5, 2008, the committee intends to discuss and make recommendations about computer aided detection and diagnosis (CAD) devices for radiological images, e.g., mammograms, chest x-rays, and computed tomography (CT) images of the lungs or ... Tue, 13 May 2008 04:00:00 GMT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfAdvisory/details.cfm?mtg=694 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfAdvisory/details.cfm?mtg=694 These are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions for April 2008. Thu, 08 May 2008 04:00:00 GMT http://www.fda.gov/cdrh/pma/pmaapr08.html http://www.fda.gov/cdrh/pma/pmaapr08.html PDF format only. Topics: Ventricular Assist Device Wed, 07 May 2008 04:00:00 GMT http://www.fda.gov/cdrh/pdf6/P060040.html http://www.fda.gov/cdrh/pdf6/P060040.html This guidance document describes the general administrative procedures FDA will use to categorize tests under CLIA. This guidance does not specifically address CLIA waiver applications. Tue, 06 May 2008 04:00:00 GMT http://www.fda.gov/cdrh/oivd/guidance/1143.html http://www.fda.gov/cdrh/oivd/guidance/1143.html The HeartMate II LVAS is a left ventricular assist device (LVAD) system; a device that helps the heart?s left ventricle (the main pumping chamber of the heart) deliver blood to the rest of the body. The HeartMate II LVAS includes... Tue, 06 May 2008 04:00:00 GMT http://www.fda.gov/cdrh/mda/docs/p060040.html http://www.fda.gov/cdrh/mda/docs/p060040.html Mon, 05 May 2008 04:00:00 GMT http://www.fda.gov/cdrh/510k/sumapr08.html http://www.fda.gov/cdrh/510k/sumapr08.html The committee will discuss, make recommendations and vote on a premarket approval application for the ProGEL Surgical Sealantsponsored by NeoMend, Inc. Thu, 01 May 2008 04:00:00 GMT http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-9537.htm http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-9537.htm The FDA, in collaboration with the National Institutes of Health (NIH) and the Juvenile Diabetes Research Foundation (JDRF), is holding a public workshop focused upon the state of the art in the research and development of an artificial pancreas. The... Wed, 30 Apr 2008 04:00:00 GMT http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-9375.htm http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-9375.htm The FDA is is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of... Wed, 30 Apr 2008 04:00:00 GMT http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-9374.htm http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-9374.htm On April 24, 2008, the committee will discuss, make recommendations, and vote on a premarket approval application, sponsored by VisionCare Technologies, Inc., for an implantable miniature telescope (IMT™). The IMT™, a visual prosthetic device, is in... Tue, 29 Apr 2008 04:00:00 GMT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfAdvisory/details.cfm?mtg=695 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfAdvisory/details.cfm?mtg=695 The FDA is reopening for 90 days, the comment period for the proposed rule, published in the Federal Register of February 20, 2002 (67 FR 7620), on the classification of encapsulated amalgam alloy and dental mercury, the reclassification of dental... Mon, 28 Apr 2008 04:00:00 GMT http://www.fda.gov/OHRMS/DOCKETS/98fr/08-1187.htm http://www.fda.gov/OHRMS/DOCKETS/98fr/08-1187.htm The U.S. Food and Drug Administration has cleared for marketing the first device made from a new form of natural rubber latex, guayule latex. The product, the Yulex Patient Examination Glove, is derived from the guayule bush, a desert plant native to... Fri, 25 Apr 2008 04:00:00 GMT http://www.fda.gov/bbs/topics/NEWS/2008/NEW01822.html http://www.fda.gov/bbs/topics/NEWS/2008/NEW01822.html PDF format only. Topics: Implantable Cardioverter Defibrillator Thu, 24 Apr 2008 04:00:00 GMT http://www.fda.gov/cdrh/pdf/P010012S037.html http://www.fda.gov/cdrh/pdf/P010012S037.html The FDA is announcing a public workshop entitled 'Coronary Drug-Eluting Stent (DES) Guidance Document Workshop.' FDA is cosponsoring the workshop with the Advanced Medical Technology Association (AdvaMed). The purpose of the workshop is to discuss the... Thu, 24 Apr 2008 04:00:00 GMT http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-8853.htm http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-8853.htm 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 notice in the Federal Register concerning each... Thu, 24 Apr 2008 04:00:00 GMT http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-8710.htm http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-8710.htm This guidance document is intended to assist industry in preparing an Abbreviated premarket notification submission (510(k)) to establish that the device is substantially equivalent to a predicate hemodialysis blood tubing set for use as the... Thu, 24 Apr 2008 04:00:00 GMT http://www.fda.gov/cdrh/ode/guidance/1649.html http://www.fda.gov/cdrh/ode/guidance/1649.html The FDA is postponing the meeting of the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee scheduled for May 16, 2008. The meeting was announced in the Federal Register of March 27, 2008 (73 FR 16315). FDA's Center for... Thu, 24 Apr 2008 04:00:00 GMT http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-8845.htm http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-8845.htm PDF format only. Topics: Stents Thu, 24 Apr 2008 04:00:00 GMT http://www.fda.gov/cdrh/pdf7/P070027.html http://www.fda.gov/cdrh/pdf7/P070027.html The FDA is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection... Tue, 22 Apr 2008 04:00:00 GMT http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-8682.htm http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-8682.htm The FDA is announcing the availability of a draft guidance for industry entitled 'Guidance for Sponsors, Industry, Researchers, Investigators, and FDA Staff: Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions:... Fri, 18 Apr 2008 04:00:00 GMT http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-8349.htm http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-8349.htm FDA has developed this guidance document to assist industry in preparing Investigational Device Exemption (IDE) applications for nocturnal home hemodialysis (NHHD) systems. These dialysis devices are intended to administer dialysis therapy in the home... Fri, 18 Apr 2008 04:00:00 GMT http://www.fda.gov/cdrh/ode/guidance/1650.html http://www.fda.gov/cdrh/ode/guidance/1650.html This document was developed to describe our recommendations for IDE applications for total artificial disc devices. It provides guidance for developers on the appropriate pre-clinical tests and clinical trial designs to adequately evaluate the safety... Fri, 18 Apr 2008 04:00:00 GMT http://www.fda.gov/cdrh/ode/guidance/1637.html http://www.fda.gov/cdrh/ode/guidance/1637.html The Talent™ Abdominal Stent Graft System is used to repair aneurysms of the aorta in the abdomen (belly). An aneurysm is a diseased, weakened and bulging section of an artery wall. The Talent™ Abdominal Stent Graft System is made of a fabric... Thu, 17 Apr 2008 04:00:00 GMT http://www.fda.gov/cdrh/mda/docs/P070027.html http://www.fda.gov/cdrh/mda/docs/P070027.html