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Rulemaking » Human Subject Protection: Acceptance of Data from Clinical Studies for Medical Devices
Human Subject Protection: Acceptance of Data from Clinical Studies for Medical Devices
Document ID: FDA-2013-N-0080-0001
Document Type: Proposed Rule
Agency: Food And Drug Administration
Topics: Administrative Practices and Procedures, Confidential Business Information, Health Records, Imports, Medical Devices, Medical Research, Reporting and Recordkeeping Requirements
February 25 2013, at 12:00 AM Eastern Standard Time
Start-End Page:
12664 - 12675
Page Count:
12
Comment Start Date:
February 25 2013, at 12:00 AM Eastern Standard Time
Comment Due Date:
May 28 2013, at 11:59 PM Eastern Standard Time
Attachments:
Preliminary Regulatory Impact Analysis of the Proposed Rule to Human Subject Protection Acceptance of Data From Clinical Studies for Medical Devices
View Attachment:
Title: Preliminary Regulatory Impact Analysis of the Proposed Rule to Human Subject Protection Acceptance of Data From Clinical Studies for Medical Devices
Human Subject Protection: Acceptance of Data from Clinical Studies for Medical Devices
Details Information
Attachments:
Preliminary Regulatory Impact Analysis of the Proposed Rule to Human Subject Protection Acceptance of Data From Clinical Studies for Medical Devices
View Attachment:Comments
View AllSubmitter: Kathleen Posted: 05/29/2013 ID: FDA-2013-N-0080-0012
May 28,2013 11:59 PM ET
Posted: 05/29/2013 ID: FDA-2013-N-0080-0013
May 28,2013 11:59 PM ET
Posted: 05/20/2013 ID: FDA-2013-N-0080-0004
May 28,2013 11:59 PM ET
Submitter: Tara Posted: 05/29/2013 ID: FDA-2013-N-0080-0011
May 28,2013 11:59 PM ET
Submitter: James Posted: 05/29/2013 ID: FDA-2013-N-0080-0009
May 28,2013 11:59 PM ET
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