This guidance document revises a guidance document issued in January 2014 entitled “Guidance for Industry: Establishing and Maintaining a List of U.S. Milk Product Manufacturers/Processors with Interest in Exporting to China” to add seafood, infant formula, and formula for young children and to clarify the procedures for establishing and maintaining the lists for each type of product. This revised guidance document explains how establishments should apply to be included on FDA’s lists of exporters to China, how FDA intends to determine whether the establishment should be recommended for inclusion for specific products, and how FDA intends to update this information.
FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe our current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA guidances means that something is suggested or recommended, but not required.
指南全文見附件： 
Guidance for Industry.pdf
