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Pre-Submission Template (general)
Please include sufficient background information to allow FDA to develop feedback for the Pre-Sub questions you pose. Keep your submission targeted and focused.
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Documents Forms ; PPS Registration Application Affidavit and Public Notice Statement, Form ; PPS Registration Procedures, Information ; Pre-Delivery Report, Form.
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Contents of a Complete Submission for Threshold
This document also provides information on what to include in submissions for products under other user fee programs. 5 This includes combination products. See
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