FDA Import Glossary — Key Terms and Abbreviations

Plain-language definitions of the terms used in U.S. FDA import clearance — FFR, Prior Notice, FSVP, DWPE, 510(k), MoCRA, and more.

FDA — Food and Drug Administration

The U.S. federal agency that regulates food, drugs, cosmetics, medical devices, and more.

CBP — Customs and Border Protection

The gateway agency for all U.S. import clearance. Reviews entries in coordination with FDA.

FFR — Food Facility Registration

FDA registration for a foreign facility exporting food to the U.S. Renewed every 2 years.

PN — Prior Notice

The process of notifying FDA of every food shipment before it arrives in the U.S.

FSVP — Foreign Supplier Verification Program

The U.S. importer's responsibility to verify the safety of its foreign supplier.

FSMA — Food Safety Modernization Act

The law that rebuilt U.S. food safety around prevention rather than reaction.

U.S. Agent — United States Agent

The U.S.-based point of contact that communicates with FDA on behalf of a foreign facility.

DWPE — Detention Without Physical Examination

Automatic detention with no inspection, applied to cargo on an Import Alert.

Import Alert — Import Alert

FDA's list of countries, manufacturers, and products with a history of violations — the basis for DWPE.

PREDICT — Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting

FDA's automated risk-screening system for imports.

Detention — Detention

A clearance hold placed on cargo that fails to meet requirements. Released or refused after a response.

Refusal — Refusal of Admission

Formal refusal of entry into the U.S. after a failed response — the goods are re-exported or destroyed.

Product Code — FDA Product Code

The code FDA uses to identify a product category. Required for entry filing.

LACF — Low-Acid Canned Food

Canned food with pH above 4.6; requires separate registration (FCE/SID) due to botulism risk.

AF — Acidified Food

Food with added acid to lower its pH (e.g., pickles). Subject to separate registration.

MoCRA — Modernization of Cosmetics Regulation Act

The 2022 cosmetics reform law that made facility registration and product listing mandatory.

INCI — International Nomenclature of Cosmetic Ingredients

The international standard naming system for cosmetic ingredients, used on ingredient labels.

NDI — New Dietary Ingredient

A new dietary supplement ingredient. Requires FDA notification 75 days before sale.

cGMP — current Good Manufacturing Practice

The current manufacturing quality standard (21 CFR 111 for supplements).

510(k) — Premarket Notification 510(k)

Premarket notification for a medical device, proving equivalence to an already-cleared device (mainly Class II).

PMA — Premarket Approval

The strictest approval process, for high-risk (Class III) medical devices.

De Novo — De Novo Classification

A classification pathway for novel low- or moderate-risk devices.

UDI — Unique Device Identification

Unique device identification — labeling with an identifier code plus GUDID registration.

QSR — Quality System Regulation (21 CFR 820)

The medical device quality-system regulation (currently transitioning to QMSR).

PMTA — Premarket Tobacco Product Application

The premarket authorization application for tobacco products and e-cigarettes.

Importer of Record — Importer of Record

The party that bears legal responsibility for customs clearance and compliance.