Mark Alan Wentworth - Comment

Document ID: FDA-2008-D-0434-0014
Document Type: Public Submission
Agency: Food And Drug Administration
Received Date: July 27 2010, at 12:00 AM Eastern Daylight Time
Date Posted: July 27 2010, at 12:00 AM Eastern Standard Time
Comment Start Date: July 8 2010, at 12:00 AM Eastern Standard Time
Comment Due Date:
Tracking Number: 80b21b66
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This is comment on Notice

Guidance for Humanitarian Device Exemption Holders, et al.; Availability: Humanitarian Device Exemption Regulation; Questions and Answers

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In the recently released "Guidance for HDE Holders, Institutional Review Boards (IRBs), Clinical Investigators, and Food and Drug Administration Staff - Humanitarian Device Exemption (HDE) Regulation: Questions and Answers", Issued July 8, 2010. (OMB Control Number 0910-0661, Docket No. FDA-2008-D-0434) there is a potential discrepancy in question #65 where reference is made to other question numbers in the document. Question 65, refers to questions 31 and 46, when infact these should probably more correctly be questions 30 and 45.

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Mark Alan Wentworth - Comment
Public Submission Posted: 07/27/2010 ID: FDA-2008-D-0434-0014

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