Who can File?

Is there anything in the legislative history of FDAMA to indicate that the filing of an FCN can only be made by special classes of manufacturers or suppliers?

Mar 2001

Question: Is there anything in the legislative history of FDAMA to indicate that the filing of an FCN can only be made by special classes of manufacturers or suppliers?

Answer: No. The legislative history makes it quite clear that anyone eligible to file a petition may file an FCN as well. FDA has also explicitly stated in its Administrative Guidance that anyone may file an FCN, and has accepted notifications for companies at various points in the chain of commerce for an FCS.

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