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150223 r ||| eng |
| 020 |
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|a 9780309158497
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| 020 |
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|a 0309158494
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| 100 |
1 |
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|a Wizemann, Theresa M.
|e [editor]
|
| 245 |
0 |
0 |
|a Public health effectiveness of the FDA 510(k) clearance process
|h Elektronische Ressource
|b balancing patient safety and innovation : 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
|
| 246 |
3 |
1 |
|a FDA 510(k) clearance process
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| 260 |
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|a Washington, D.C.
|b National Academies Press
|c [2010], ©2010, 2010
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| 300 |
|
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|a xii, 128 pages
|b illustrations (some color)
|c 23 cm
|
| 505 |
0 |
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|a Introduction -- Legislative history of the Medical Device Amendments of 1976 -- Premarket notification -- The medical device industry innovation ecosystem -- The global framework for regulation of medical devices -- Public comments
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| 505 |
0 |
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|a Includes bibliographical references
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| 653 |
|
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|a Equipment Safety / standards
|
| 653 |
|
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|a United States
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| 653 |
|
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|a Device Approval / legislation & jurisprudence
|
| 653 |
|
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|a Device Approval / standards
|
| 710 |
2 |
|
|a Institute of Medicine (U.S.)
|b Board on Population Health and Public Health Practice
|
| 710 |
2 |
|
|a Institute of Medicine (U.S.)
|b Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process
|
| 041 |
0 |
7 |
|a eng
|2 ISO 639-2
|
| 989 |
|
|
|b NCBI
|a National Center for Biotechnology Information
|
| 856 |
4 |
0 |
|u https://www.ncbi.nlm.nih.gov/books/NBK209791
|3 Volltext
|n NLM Bookshelf Books
|3 Volltext
|
| 082 |
0 |
|
|a 610
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| 082 |
0 |
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|a 340
|