Certification of Compliance
FDAAA 801 requires that a certification form accompany certain human drug, biological, and device product applications/submissions to FDA.
- Certification of Compliance Form 3674 For more information, please refer to the following FDA guidance: http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM048364.pdf
For more information, Please refer to the following FDA Guidance:
See the statutory provision for Certification to Accompany Drug, Biological Product, and Device Submission:
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