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Draeger Medical GmbH - Comment

Document ID: FDA-2011-D-0469-0018
Document Type: Public Submission
Agency: Food And Drug Administration
Received Date: September 18 2011, at 12:00 AM Eastern Daylight Time
Date Posted: September 27 2011, at 12:00 AM Eastern Standard Time
Comment Start Date: June 22 2011, at 12:00 AM Eastern Standard Time
Comment Due Date: September 19 2011, at 11:59 PM Eastern Standard Time
Tracking Number: 80f21094
View Document:  View as format xml

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We generally appreciate that the draft for usability engineering provides more clarification about the usability engineering process the FDA expects. However, as a major concern we would like to address the issue adressed in the uploaded file

Attachments:

Draeger Medical GmbH - Comment, Comments on Usabilty Guidance

Title:
Draeger Medical GmbH - Comment, Comments on Usabilty Guidance

View Attachment: View as format pdf View as format msw8

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