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The Medical Device Approval Process and Related Legislative Issues (CRS Report for Congress)

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Release Date Revised April 21, 2010
Report Number RL32826
Report Type Report
Authors Erin D. Williams, Specialist in Public Health and Bioethics
Source Agency Congressional Research Service
Older Revisions
  • Premium   Revised March 20, 2010 (35 pages, $24.95) add
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Summary:

This report contains the legislative history of medical device regulation, describes FDA'sapproval process for medical devices, and provides an overview of the medical device-relatedlegislative issues facing Congress.This report will be updated as events warrant.Bills: H.R. 3962, H.R. 3590, S. 540, H.R. 1346, H.R. 1086, S. 45, S. 1324, H.R. 1321, S. 391), H.R. 759, S. 882, S. 301, H.R. 3138, H.R. 3261, H.R. 3261, H.R. 1699, H.R. 1452, S. 717, S. 819, H.R. 1878, S. 586, H.R. 1483, H.R. 1380, H.R. 1236, H.R. 1142, S. 422, H.R. 1032, H.R.1021, H.R. 554, S. 332, S. 254, H.R. 574, S. 236, H.R. 463, S. 21, H.R. 2088, H.Res. 577, S.1746, H.R. 1531, S. 1089, H.R. 1737, S. 1733, S. 1591, H.R. 3560, H.R. 2454, S. 2998, H.R. 3012, H.R. 3090, H.R. 3242, H.R. 3932