FDABridge Blog

Articles for exporters dealing with FDA paperwork

Read practical guides about food registration, MoCRA, drug filings, and the paperwork that comes before your products enter the market.

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FoodMay 15, 2026

How a Foreign Company Can Export Food to the United States: The FDA Requirements

Map the facility, importer and shipment roles before exporting food to the US. Check registration exemptions, UFI, US Agent, FSVP, labels and Prior Notice separately.

DrugMay 12, 2026

What Is OMUFA? FY2027 Fees for Foreign OTC Manufacturers

OMUFA fees depend on a facility's actual OTC monograph drug activity. Check the FY2027 fee period, qualifying exclusions and FDA invoice before budgeting.

DrugMay 8, 2026

FDA Drug Establishment Registration: What Foreign Manufacturers Must File

Foreign drug manufacturers must register their establishments with the FDA before distributing drugs in the US. Here is who must register, what is required, and how the annual cycle works.

DrugMay 5, 2026

What Is an NDC Number and How Foreign Drug Manufacturers Obtain One

Understand the marketing company’s labeler code, FDA’s current NDC format, the confirmation SPL, and the separate establishment and product-listing duties.

DrugMay 2, 2026

FDA Drug Labeling Requirements: What Foreign Manufacturers Must Include on US Packaging

FDA drug labeling requirements specify exactly what must appear on US drug packaging — from the Drug Facts panel to allergen declarations. Foreign manufacturers must meet every requirement before the first shipment.

FDA StoriesMay 2, 2026

FDA Stories #003 — An SPF Moisturizer's US Drug and Cosmetic Duties

An illustrative Turkish-brand scenario shows why an SPF claim can make a moisturizer both a drug and a cosmetic in the US, and why the filing and fee paths must be checked separately.

DeviceApr 28, 2026

Medical Device Labeling Symbols: What Foreign Manufacturers Must Know for US Market Entry

Medical device labeling in the US requires specific symbols for proper communication. Foreign manufacturers must understand FDA-accepted symbol standards before exporting devices to the American market.

FoodApr 24, 2026

FDA Registration Numbers Explained: Check Your Filing Record

A food registration number, food DUNS/UFI and cosmetic FEI identify different records. Use this checklist to avoid confusing account access with registration status.

FoodApr 20, 2026

FDA Inspections of Foreign Registered Facilities: What to Expect and How to Prepare

The FDA has authority to inspect foreign food and drug facilities. Understanding how inspections are triggered, what inspectors look for, and what the outcomes mean helps foreign manufacturers stay prepared.

CosmeticsApr 17, 2026

US Cosmetic Labeling: Principal Display Panel and MoCRA Requirements

Check the established PDP and information-panel rules, current MoCRA label duties and pending fragrance-allergen rulemaking without treating a professional review as FDA approval.

FoodApr 14, 2026

FDA Food Facility Registration: Step-by-Step Tasks for Foreign Facilities

Check whether a facility must register, match its DUNS/UFI, confirm its U.S. Agent and account access, then submit and retain FDA registration evidence.

FoodApr 10, 2026

Why the FDA Rejects Food Facility Registrations: Common Mistakes Foreign Manufacturers Make

FDA food facility registration rejections are almost always preventable. The most common causes are DUNS mismatches, missing US Agent information, and incorrect product category codes.

EUApr 9, 2026

EU Regulation 1223/2009: What Non-EU Cosmetic Brands Must Know Before Selling in Europe

EU Regulation 1223/2009 sets the legal framework for every cosmetic product in Europe. Here is what non-EU brands must have in place before market entry.

FoodApr 8, 2026

Exporting Food to the United States from Southeast Asia: FDA Compliance for ASEAN Manufacturers

To export food to USA from Southeast Asia, ASEAN manufacturers must hold FDA facility registration, a DUNS number, a US Agent, and compliant labels.

CosmeticsApr 7, 2026

MoCRA Cosmetic Facility Registration: Who Registers and What Changed

A practical guide to facility owner/operator registration, the label-named responsible person, FEI, exemptions, renewal and product listing under FD&C Act section 607.

FoodApr 7, 2026

What Is a UFI Number and How It Affects FDA Food Facility Registration

The UFI — Unique Facility Identifier — is the FDA's term for the identifier required in food facility registration. The DUNS number currently serves this role. Here is what foreign facilities need to know.

FoodApr 6, 2026

FDA Packaged Food Export Checklist: What Foreign Manufacturers Must Have Ready

A complete FDA packaged food export checklist covering registration, DUNS, US Agent, Prior Notice, and label compliance for foreign manufacturers.

FoodApr 5, 2026

What Is a US FDA Agent for a Foreign Food Facility?

Foreign food facilities subject to FDA registration need a US Agent. Understand the appointment, communication role, coverage agreement and renewal responsibilities.