Public health effectiveness of the FDA 510(k) clearance process: measuring postmarket performance and other select topics : workshop report
Gespeichert in:
| Format: | Elektronisch E-Book |
|---|---|
| Sprache: | English |
| Veröffentlicht: |
Washington, D.C.
National Academies Press
c2011
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| Schlagworte: | |
| Online-Zugang: | FAW01 FAW02 Volltext |
| Beschreibung: | Paralleltitel: FDA 510(k) clearance process Includes bibliographical references Introduction -- - Food and Drug Administration Postmarket Surveillance Activities and Recall Studies of Medical Devices -- - Non-Food and Drug Administration Sources of Adverse Event Data -- - Postmarket Surveillance of Medical Devices: Panel Discussion -- - Other Select Topics -- - Appendix A - Workshop Agenda -- - Appendix B - Biographic Information on Invited Speakers, Panelists, and Authors of Commissioned Papers -- - Appendix C - 510(k) Premarket Notification Analysis of FDA Recall Data -- - Appendix D - Trustworthy Medical Device Software "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 |
| Beschreibung: | 1 Online-Ressource (xiv, 118 p.) |
| ISBN: | 0309162068 0309162076 1283134977 9780309162067 9780309162074 9781283134972 |
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| 245 | 1 | 0 | |a Public health effectiveness of the FDA 510(k) clearance process |b measuring postmarket performance and other select topics : workshop report |c Theresa 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 |
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| 500 | |a Paralleltitel: FDA 510(k) clearance process | ||
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| 500 | |a Introduction -- - Food and Drug Administration Postmarket Surveillance Activities and Recall Studies of Medical Devices -- - Non-Food and Drug Administration Sources of Adverse Event Data -- - Postmarket Surveillance of Medical Devices: Panel Discussion -- - Other Select Topics -- - Appendix A - Workshop Agenda -- - Appendix B - Biographic Information on Invited Speakers, Panelists, and Authors of Commissioned Papers -- - Appendix C - 510(k) Premarket Notification Analysis of FDA Recall Data -- - Appendix D - Trustworthy Medical Device Software | ||
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| spelling | Public health effectiveness of the FDA 510(k) clearance process measuring postmarket performance and other select topics : workshop report Theresa 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 FDA 510(k) clearance process Washington, D.C. National Academies Press c2011 1 Online-Ressource (xiv, 118 p.) txt rdacontent c rdamedia cr rdacarrier Paralleltitel: FDA 510(k) clearance process Includes bibliographical references Introduction -- - Food and Drug Administration Postmarket Surveillance Activities and Recall Studies of Medical Devices -- - Non-Food and Drug Administration Sources of Adverse Event Data -- - Postmarket Surveillance of Medical Devices: Panel Discussion -- - Other Select Topics -- - Appendix A - Workshop Agenda -- - Appendix B - Biographic Information on Invited Speakers, Panelists, and Authors of Commissioned Papers -- - Appendix C - 510(k) Premarket Notification Analysis of FDA Recall Data -- - Appendix D - Trustworthy Medical Device Software "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 United States / Food and Drug Administration United States Food and Drug Administration Congresses HEALTH & FITNESS / Safety bisacsh Device Approval / Congresses / standards / United States Device Approval / Congresses / legislation & jurisprudence / United States Equipment Safety / Congresses / standards / United States Public health Equipment and supplies Standards United States Congresses Public health United States Congresses USA (DE-588)1071861417 Konferenzschrift gnd-content Wizemann, Theresa M. Sonstige oth Institute of Medicine (U.S.) Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process Sonstige oth http://search.ebscohost.com/login.aspx?direct=true&scope=site&db=nlebk&db=nlabk&AN=372504 Aggregator Volltext |
| spellingShingle | Public health effectiveness of the FDA 510(k) clearance process measuring postmarket performance and other select topics : workshop report United States / Food and Drug Administration United States Food and Drug Administration Congresses HEALTH & FITNESS / Safety bisacsh Device Approval / Congresses / standards / United States Device Approval / Congresses / legislation & jurisprudence / United States Equipment Safety / Congresses / standards / United States Public health Equipment and supplies Standards United States Congresses Public health United States Congresses |
| subject_GND | (DE-588)1071861417 |
| title | Public health effectiveness of the FDA 510(k) clearance process measuring postmarket performance and other select topics : workshop report |
| title_alt | FDA 510(k) clearance process |
| title_auth | Public health effectiveness of the FDA 510(k) clearance process measuring postmarket performance and other select topics : workshop report |
| title_exact_search | Public health effectiveness of the FDA 510(k) clearance process measuring postmarket performance and other select topics : workshop report |
| title_full | Public health effectiveness of the FDA 510(k) clearance process measuring postmarket performance and other select topics : workshop report Theresa 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 |
| title_fullStr | Public health effectiveness of the FDA 510(k) clearance process measuring postmarket performance and other select topics : workshop report Theresa 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 |
| title_full_unstemmed | Public health effectiveness of the FDA 510(k) clearance process measuring postmarket performance and other select topics : workshop report Theresa 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 |
| title_short | Public health effectiveness of the FDA 510(k) clearance process |
| title_sort | public health effectiveness of the fda 510 k clearance process measuring postmarket performance and other select topics workshop report |
| title_sub | measuring postmarket performance and other select topics : workshop report |
| topic | United States / Food and Drug Administration United States Food and Drug Administration Congresses HEALTH & FITNESS / Safety bisacsh Device Approval / Congresses / standards / United States Device Approval / Congresses / legislation & jurisprudence / United States Equipment Safety / Congresses / standards / United States Public health Equipment and supplies Standards United States Congresses Public health United States Congresses |
| topic_facet | United States / Food and Drug Administration United States Food and Drug Administration Congresses HEALTH & FITNESS / Safety Device Approval / Congresses / standards / United States Device Approval / Congresses / legislation & jurisprudence / United States Equipment Safety / Congresses / standards / United States Public health Equipment and supplies Standards United States Congresses Public health United States Congresses USA Konferenzschrift |
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