Description
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.
Key Topics
Terms and concepts identified from this document
Scope & Applicability
Stakeholders
3The IOR's name, address, and FEI are required for the WEF request.
Entity involved in the movement of product to the FTZ
Entity responsible for submitting NDINs
Regulatory Context
Regulatory Activities
2FDA review to determine if a product is a good candidate for WEF; FDA assessment of products before filing a weekly entry with CBP.
Program allowing merchandise withdrawn from FTZs to be subject to a single estimated weekly entry; A request submitted to CBP for weekly entry of FDA-regulated products.
Attributes
3Inspection classification (VAI) decreasing likelihood of positive assessment.
Inspection classification (OAI) decreasing likelihood of positive assessment.
Inspection classification (NAI) increasing likelihood of positive assessment.
Identified Hazards
Hazards
1Risks associated with product design attributes
Related CFR Sections (1)
- 21CFR10.115§ 10.115 Good guidance practices.
(a) What are good guidance practices? Good guidance practices (GGP's) are FDA's policies and procedures for developing, issuing, and using guidance documents.Read full regulation →
See Also (8)
- An Acceptable Circular of Information for the Use of Human Blood and Blood Components: Guidance for Industry (Status: Final)
- FDA Review of Vaccine Labeling Requirements for Warnings, Use Instructions, and Precautionary Information: Guidance for Industry (Status: Final)
- Recognition and Use of a Standard for Uniform Blood and Blood Component Container Labels: Guidance for Industry (Status: Final)
- Implementation of Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Source Plasma: Guidance for Industry (Status: Final)
- Implementation of Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Blood and Blood Components: Guidance for Industry (Status: Final)
- Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) - Small Entity Compliance Guide: Guidance for Industry (Status: Final)
- CPG Sec. 280.100 - Stability Requirements - Licensed In Vitro Diagnostic Products (Status: Final)
- CPG Sec. 280.110- Microbiological Control Requirements-Licensed Anti-Human Globulin and Blood Grouping Reagents (Status: Final)