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- 2011277317 contributor B12165462.
- 2011277317 created "c2011.".
- 2011277317 date "2011".
- 2011277317 date "c2011.".
- 2011277317 dateCopyrighted "c2011.".
- 2011277317 description "Includes bibliographical references and index.".
- 2011277317 description "Introduction -- Key medical-device legislative and regulatory actions -- Components of US medical-device regulation -- The 510(k) clearance process -- Postmarketing surveillance, compliance, and enforcement -- External factors that affect the medical-device regulatory system -- Conclusions and recommendations -- A history of medical-device legislation and regulation in the United States.".
- 2011277317 extent "xx, 298 p. :".
- 2011277317 hasFormat "Also available online in Open Book format via the National Academies Press home page.".
- 2011277317 identifier "0309212421 (pbk.)".
- 2011277317 identifier "9780309212427 (pbk.)".
- 2011277317 identifier catalog.php?record%5Fid=13150.
- 2011277317 identifier catalog.php?record_id=13150.
- 2011277317 isFormatOf "Also available online in Open Book format via the National Academies Press home page.".
- 2011277317 issued "2011".
- 2011277317 issued "c2011.".
- 2011277317 language "eng".
- 2011277317 publisher "Washington, D.C. : National Academies Press,".
- 2011277317 relation "Also available online in Open Book format via the National Academies Press home page.".
- 2011277317 spatial "United States.".
- 2011277317 subject "Device Approval legislation & jurisprudence United States.".
- 2011277317 subject "Equipment Safety United States.".
- 2011277317 subject "Equipment and Supplies standards United States.".
- 2011277317 subject "Medical instruments and apparatus Safety regulations United States.".
- 2011277317 subject "Medical instruments and apparatus.".
- 2011277317 subject "Product safety Law and legislation United States.".
- 2011277317 subject "R856.6 .I57 2011".
- 2011277317 subject "United States. Food and Drug Administration.".
- 2011277317 subject "WB 26 I59e 2011".
- 2011277317 tableOfContents "Introduction -- Key medical-device legislative and regulatory actions -- Components of US medical-device regulation -- The 510(k) clearance process -- Postmarketing surveillance, compliance, and enforcement -- External factors that affect the medical-device regulatory system -- Conclusions and recommendations -- A history of medical-device legislation and regulation in the United States.".
- 2011277317 title "Medical devices and the public's health : the FDA 510(k) clearance process at 35 years / 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.".
- 2011277317 type "text".