Medical devices and the public's health : the FDA 510(k) clearance process at 35 years

• Material Type: 図書
• ISBN: 9780309212427 (pbk.); 0309212421 (pbk.)
• Title: Medical devices and the public's health : the FDA 510(k) clearance process at 35 years
• Author/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.
• Author Heading: Institute of Medicine (U.S.). Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process.
• Publication, Distribution, etc.: Washington, D.C. : The National Academies Press
• Publication Date: [2011]
• Publication Date (W3CDTF): 2011
• Extent: xx, 298 pages
• Other physical details: illustrations
• Size: 23 cm
• Place of Publication (Country Code): US
• Text Language Code: eng
• Content Type: text
• Media Type: unmediated
• Carrier Type: volume
• Subject Heading: Medical instruments and apparatus.; Medical instruments and apparatus--Safety regulations--United States.; Product safety--Law and legislation--United States.; United States. Food and Drug Administration.; Equipment and Supplies--standards--United States.; Device Approval--legislation & jurisprudence--United States.; Equipment Safety--United States.
• LCC: R856.6
• NDLC: M361; SC221
• Target Audience: 一般
• Note (Bibliography): Includes bibliographical references and index.
• Note (Additional Physical Form Available): Also available online in Open Book format via the National Academies Press home page.
• Holding library: 国立国会図書館
• Call No.: M361-B448
• Related Material (URI): http://www.nap.edu/catalog.php?record%5Fid=13150
• Has Format (URI): http://www.nap.edu/catalog.php?record_id=13150
• Data Provider (Database): 国立国会図書館 : 国立国会図書館蔵書; https://ndlsearch.ndl.go.jp
• Bibliographic ID (NDL): 024094315; http://id.ndl.go.jp/bib/024094315
• LC Control Number: 2011277317; https://lccn.loc.gov/2011277317
• OCLC No.: 747314134; https://www.worldcat.org/oclc/747314134
• Cataloging Rule: RDA
• Bibliographic Record Category (NDL): 211

• Contents: IntroductionKey medical-device legislative and regulatory actionsComponents of US medical-device regulation...
• Summary, etc.: "Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) p...