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FDA Regulatory Approval
Documents
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NVCA/MedIC Comments on FDA Alternative Approval Pathway
02/27/2013
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Alternative FDA Approval Pathway Presentation - Feb 4, 2013
02/04/2013
Download
FDA 2012 Benefit/Risk Guidance – VC Perspective
09/07/2012
Download
Medical Device Innovation Ecosystem Presentation
09/07/2012
Download
Summary of FDASIA Drug and Device Provisions July 2012
07/12/2012
Download
NVCA and MedIC Commend Signing of FDA Safety and Innovation Act
07/09/2012
Download
NVCA & MedIC Applaud Passage of FDA User Fee Reauthorization Bills
05/31/2012
Download
NVCA Member Testifies on MDUFA Re-Authorization
02/15/2012
Download
NVCA/MedIC Comments on CDHR New Benefit Risk Framework Guidance - worksheet
11/17/2011
Download
NVCA/MedIC Comments on CDHR New Benefit Risk Framework Guidance
11/17/2011
Download
NVCA/MedIC Comments on CDHR Recommendations to Clinical Trial Designs
11/14/2011
Download
NVCA/MedIC Comment on IOM Recommendations for 501(k) Process
10/27/2011
Download
NVCA/MedIC Comment on CDHR Recommendation for Improvement to 510(k) Process
10/25/2011
Download
MedIC Releases Vital Signs - Data Slides
10/06/2011
Download
MedIC Releases Vital Signs - Press Release
10/06/2011
Download
NVCA Member Testifies on Impact of Medical Device and Drug Regulation
09/27/2011
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NVCA Member Jonathan Leff Testifies on Improving FDA Approval Process
07/12/2011
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NVCA Comments on Medical Device Innovation Initiative
07/05/2011
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NVCA Board Member Jack Lasersohn Testifies on FDA Reform Priorities
06/06/2011
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NVCA and MedIC FDA Reform Priorities - April 2011
04/08/2011
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