MARC Record from Library of Congress

LEADER: 02919nam a22003377a 4500
001 2011284660
003 DLC
005 20111029122149.0
008 110927s2011 dcua b 100 0 eng c
010 $a 2011284660
020 $a0309162068
020 $a9780309162067
035 $a(OCoLC)ocn694600804
040 $aYDXCP$beng$cYDXCP$dNRZ$dUPM$dCDX$dOCLCQ$dDLC
042 $apcc
043 $an-us---
050 00 $aRA399.A3$bP82 2011
245 00 $aPublic health effectiveness of FDA 510(k) clearance process :$bmeasuring postmarket performance and other select topics : workshop report /$cTheresa Wizemann, editor ; Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process, Board on Population Health and Public Health Practice, Institute of Medicine of the National Academies.
246 17 $aFDA 510(k) clearance process
260 $aWashington, D.C. :$bNational Academies Press,$cc2011.
300 $axiv, 118 p. :$bill. (some col.) ;$c23 cm.
504 $aIncludes bibliographical references.
505 0 $aIntroduction -- Food and Drug Administration postmarking surveillance activities and recall studies of medical devices.
520 $a"The Food and Drug Administration (FDA) is responsible for ensuring that medical devices are safe and effective before they go on the market. Section 510(k) of the Federal Food, Drug, and Cosmetic Act requires a manufacturer of medical devices to notify FDA of its intent to market a medical device at least 90 days in advance. That window of time allows FDA to evaluate whether the device is substantially equivalent to a product already legally on the market (called a predicate), in which case the device does not need to go through the premarket approval (PMA) process. As part of its assessment of the FDA's premarket clearance process for medical devices, the Institute of Medicine (IOM) held a workshop on July 28, 2010 to discuss how medical devices are monitored for safety after they are available to consumers. Its primary focus was on monitoring the safety of marketed medical devices, including FDA's postmarket surveillance activities, analysis of safety concerns that resulted in medical device recalls, and non-FDA sources of adverse-event information. Public Health Effectiveness of the FDA 501(K) Clearance Process summarizes the views of the workshop participants."--Publisher's description.
530 $aAlso available in Open Book format via the National Academies Press home page.
610 10 $aUnited States.$bFood and Drug Administration$vCongresses.
650 0 $aPublic health$xEquipment and supplies$xStandards$zUnited States$vCongresses.
650 0 $aPublic health$zUnited States$vCongresses.
700 1 $aWizemann, Theresa M.
710 2 $aInstitute of Medicine (U.S.).$bCommittee on the Public Health Effectiveness of the FDA 510(k) Clearance Process.
856 41 $uhttp://www.nap.edu/catalog.php?record_id=13020