Day

September 29, 2017
29
Sep

FDA Pre-submission Meeting Guidance

September 29, 2017
The U.S. Food and Drug Administration released guidance document, “Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff,” dated September 29, 2017. The guidance lists and explains the process for requesting meetings with the FDA. It explains proper use of these meetings, including examples of appropriate...
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IEC 29119-1 Software and System Testing

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