The file list that FDA certificated needs to submitted
1.  The entrustment agreement (signed by the legal representative and stamped with the official seal of the company)
2. Legal status document (business license, enterprise legal person certificate, etc., copy and affix official seal)
3. Certificate of validity or production permit within the period of validity (copy with official seal)
4. Formal application
5. product specification
6.  Product technical manual
7.  Product related drawings
8.  FDA new additions required for submission of other documents (if any)
 
The FDA authentication cycle
Different product of FDA certification cycle is not the same, the general certification cycle is around 10--50 working days.