| Description |
1 online resource (xiv, 118 pages) : illustrations (chiefly color) |
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text file |
| Bibliography |
Includes bibliographical references. |
| Contents |
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. |
| Summary |
"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. |
| Local Note |
eBooks on EBSCOhost EBSCO eBook Subscription Academic Collection - North America |
| Subject |
United States. Food and Drug Administration -- Congresses.
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United States. Food and Drug Administration. |
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United States. Food and Drug Administration. |
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Public health -- Equipment and supplies -- Standards -- United States -- Congresses.
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Public health. |
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Equipment and supplies. |
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United States. |
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Public health -- United States -- Congresses.
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Device Approval. |
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Equipment Safety. |
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United States. |
| Genre/Form |
Congress.
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Electronic books.
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Electronic resource.
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Conference papers and proceedings.
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Conference papers and proceedings.
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| Added Author |
Wizemann, Theresa M.
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Institute of Medicine (U.S.). Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process.
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| Running Title |
FDA 510(k) clearance process |
| Other Form: |
Print version: Public health effectiveness of FDA 510(k) clearance process. Washington, D.C. : National Academies Press, ©2011 0309162068 (OCoLC)694600804 |
| ISBN |
9780309162074 (electronic book) |
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0309162076 (electronic book) |
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1283134977 |
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9781283134972 |
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0309162068 |
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9780309162067 |
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