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Draft Guidance for Industry and Food and Drug Administration Staff: Enforcement Policy for Premarket Notification Requirements for Certain In Vitro Diagnostic and Radiology Devices

Document ID: FDA-2011-D-0476-0001
Document Type: Notice
Agency: Food And Drug Administration
Topics: No Topics associated with this document
Federal Register Number: 2011-17352
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Details Information

Document Subtype: Notice of Availability
Received Date: July 12 2011, at 12:00 AM Eastern Daylight Time
Start-End Page: 40921 - 40922
Page Count: 2
Comment Start Date: July 12 2011, at 12:00 AM Eastern Standard Time
Comment Due Date: October 11 2011, at 11:59 PM Eastern Standard Time

Comments

    View All
Total: 7
American Association for Clinical Chemistry (AACC) - Comment
Posted: 09/16/2011     ID: FDA-2011-D-0476-0002

Oct 11,2011 11:59 PM ET
KHN Solutions LLC - Comment
Posted: 10/13/2011     ID: FDA-2011-D-0476-0003

Oct 11,2011 11:59 PM ET
Advanced Medical Technology Association (AdvaMed) - Comment
Posted: 10/13/2011     ID: FDA-2011-D-0476-0005

Oct 11,2011 11:59 PM ET
KHN Solutions LLC - Comment
Posted: 10/13/2011     ID: FDA-2011-D-0476-0007

Oct 11,2011 11:59 PM ET
Mossman Associates, Inc. - Comment
Posted: 10/28/2011     ID: FDA-2011-D-0476-0008

Oct 11,2011 11:59 PM ET

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