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FDA Home3 Medical Devices4 Databases5CFRCodeofFederalRegulationsTitle21 TheinformationonthispageiscurrentasofApril12015. ForthemostuptodateversionofCFRTitle21,gototheElectronicCodeofFederalRegulations
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CITE21CFR314 is a form used for reporting specific information related to FDA-regulated products.
Manufacturers or distributors of FDA-regulated products are required to file CITE21CFR314.
CITE21CFR314 can be filled out electronically on the FDA's designated online portal.
The purpose of CITE21CFR314 is to ensure the compliance and safety of FDA-regulated products.
Information such as product details, manufacturing processes, adverse events, and quality control measures must be reported on CITE21CFR314.
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