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Get FDA 3636 2018

T follow the appropriate guide (21 CFR 1002.7). If the report does not follow an applicable guide it must contain a sufficient justification for any deviations. The submitter of the report will receive an acknowledgment letter with the accession number we assign to the report. Please reference this accession number in the future when providing additional information about this model family in either a supplement or the annual report. If a report is incomplete or inadequate CDRH may reject it and.

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