Certification of Compliance

FDAAA 801 requires that a certification form accompany certain human drug, biological, and device product applications/submissions to FDA.

For more information, Please refer to the following FDA Guidance:

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm125335.htm

See the statutory provision for Certification to Accompany Drug, Biological Product, and Device Submission:

http://www.gpo.gov/fdsys/pkg/PLAW-110publ85/pdf/PLAW-110publ85.pdf#page=96

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