Regulatory Definitions.
Canonical definitions for the FDA compliance terms that matter most — designed for precision, consistency, and instant retrieval across every workflow.
Core Regulatory Terms
Each term includes an authoritative short definition, expandable regulatory context, and direct links to the tools and services where these concepts are applied.
FDA U.S. Agent
A U.S.-based representative designated by foreign establishments to serve as the primary point of contact for all FDA communications, including inspections, recalls, and regulatory correspondence.
MoCRA
The Modernization of Cosmetics Regulation Act of 2022, which significantly expanded FDA authority over cosmetic product registration, ingredient listing, adverse event reporting, and facility registration.
FSVP
The Foreign Supplier Verification Program, a FSMA-mandated program requiring U.S. importers to verify that their foreign suppliers produce food meeting U.S. safety standards equivalent to the Preventive Controls and Produce Safety rules.
Import Alert
An FDA enforcement mechanism that authorizes field staff to detain imported products without physical examination (DWPE) when a pattern of violations or compliance risks has been identified for a specific product, firm, or country.
SPL (Structured Product Labeling)
Structured Product Labeling is the mandatory XML-based standard used to submit drug establishment registration and product listing data to the FDA through the FDA Electronic Submissions Gateway or SPL Xforms.
UDI / GUDID
UDI (Unique Device Identification) is a standardized identification system for medical devices; GUDID (Global Unique Device Identification Database) is the FDA's public database that stores and retrieves UDI-related device information.
See Terms in Action
Definitions become powerful when connected to tools, guides, and workflows. Explore where these concepts live in practice.
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