Introduction

The purpose of this Compliance Policy Guide (CPG) is to provide guidance to FDA staff and trade regarding requests to the FDA, for a preliminary admissibility assessment of FDA-regulated products that would be included in a weekly entry filing (WEF).  The FDA recommends that persons who wish to file a weekly entry with the U.S. Customs and Border Protection (CBP) under 19 CFR 146.63(c)(1), request a preliminary admissibility assessment from the FDA before filing a request for a weekly entry with the CBP.  The preliminary admissibility assessments are for the purpose of FDA reviewing whether the product is a good candidate for WEF, based on compliance with FDA-administered regulatory requirements and other factors relevant to FDA’s admissibility review.  This CPG describes what information the FDA needs to make a preliminary admissibility assessment.  

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities.  Instead, a guidance describes 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 guidance means that something is suggested or recommended, but not required.