Frequently Asked Questions

Yes, in most cases. Any foreign facility that manufactures, processes, packs, or holds food, drugs, medical devices, or cosmetics intended for U.S. consumption must register with the FDA before exporting to the United States.

Failure to register can result in your shipments being refused at the U.S. border, FDA import alerts, and significant financial losses. Registration is not just a formality — it's a legal requirement under the Federal Food, Drug, and Cosmetic Act.

It depends on the product type:

• Food facilities: Must be renewed every 2 years (odd-numbered years, October 1 – December 31)
• Medical device establishments: Annual renewal required (October 1 – December 31)
• Drug establishments: Annual renewal required
• Cosmetic facilities (MoCRA): Annual renewal required

An FDA Establishment Identifier (FEI) is a unique 7-10 digit number assigned by the FDA to every registered facility. It's your official FDA identity number used in all FDA communications, import screenings, and product listings.

You receive your FEI number automatically upon successful FDA facility registration. If you've registered before and need to find your existing FEI, you can search the FDA's public database or we can look it up for you.

• 🌿 Food & Beverages — including packaged foods, snacks, beverages, spices, condiments
• 💊 Dietary Supplements — vitamins, minerals, herbal products, protein powders
• 🏭 Low-Acid Canned Foods (LACF) — require FCE + SID registration
• 🩺 Medical Devices — from bandages to complex diagnostic equipment
• 💊 Drugs & Pharmaceuticals — OTC and prescription drugs
• ✨ Cosmetics — under the new MoCRA regulations since 2023
• 🐾 Animal Food — pet food, animal feed, livestock supplements

Some categories have exemptions for very small businesses. Contact us for a free assessment of your specific situation.

A U.S. Agent is a person or company physically located in the United States who acts as the official point of contact between a foreign facility and the FDA.

The FDA requires every foreign food facility, medical device establishment, drug establishment, and cosmetic facility to designate a U.S. Agent. The U.S. Agent:

• Receives official FDA communications on your behalf
• Assists the FDA in scheduling inspections of your facility
• Is reachable during U.S. business hours
• Forwards FDA notices and requests to you promptly

As your designated U.S. Agent, Regovant LLC:

• Is listed on your official FDA registration as your U.S. contact
• Monitors your FDA account for any communications, alerts, or requests
• Notifies you immediately if the FDA contacts us regarding your facility
• Assists with scheduling and coordinating FDA inspections if required
• Provides you with your FDA registration certificate and FEI number
• Reminds you of upcoming renewal deadlines
• Handles the renewal submission on your behalf

Absolutely. You can change your designated U.S. Agent at any time by updating your FDA registration. The process takes just a few days and there is no fee charged by the FDA for the change.

Simply contact us and we will handle the entire transfer process for you, including notifying the FDA of the change and ensuring continuity of coverage during the transition.

Under the Bioterrorism Act of 2002 and the Food Safety Modernization Act (FSMA), any domestic or foreign facility that manufactures, processes, packs, or holds food for human or animal consumption in the United States must register with the FDA.

This includes factories, warehouses, cold storage facilities, and processing plants — even if the food passes through a U.S. importer before reaching consumers.

FCE (Food Canning Establishment) registration and SID (Scheduled Process Identification) filing are additional requirements for manufacturers of thermally processed low-acid foods in hermetically sealed containers — such as canned vegetables, soups, sauces, pet food, and similar products.

These are separate from the general food facility registration and are required under 21 CFR Part 108 and Part 113.

• FCE: Registers your establishment as a low-acid canned food processor
• SID: Documents and files your specific thermal processing schedule for each product

Dietary supplements exported to the U.S. must comply with FDA labeling regulations under 21 CFR Part 101 and the DSHEA (Dietary Supplement Health and Education Act). Key requirements include:

• Statement of identity ("Dietary Supplement")
• Net quantity of contents
• Supplement Facts panel (not Nutrition Facts)
• Ingredient list in descending order by weight
• Name and address of manufacturer, packer, or distributor
• Allergen declarations
• Proper structure/function claims (if any) with required disclaimer

Our Standard and Advanced Label Review services cover all of these requirements and provide a detailed compliance report.

No — not every device requires 510(k) clearance. Whether you need a 510(k) depends on the device's classification:

• Class I devices (lowest risk, e.g. bandages, exam gloves): Mostly exempt from 510(k), but still require establishment registration and device listing
• Class II devices (moderate risk, e.g. X-ray equipment, contact lenses): Most require 510(k) premarket notification
• Class III devices (highest risk, e.g. implantable pacemakers): Require Premarket Approval (PMA), not 510(k)

The Unique Device Identification (UDI) system requires most medical devices sold in the U.S. to carry a unique identifier on their label and packaging. The UDI consists of a Device Identifier (DI) and a Production Identifier (PI).

Device information must also be submitted to the FDA's GUDID (Global Unique Device Identification Database). Compliance deadlines have already passed for most device classes — meaning if you're selling in the U.S. now, you likely need to be compliant.

Regovant assists with GUDID account creation and UDI listing submissions.

An NDC (National Drug Code) Labeler Code is a unique 4 or 5-digit identifier assigned by the FDA to each drug manufacturer or distributor. It forms the first segment of a drug product's complete 10-digit NDC number.

Every drug product commercially marketed in the United States must have an NDC number on its label. You cannot sell or list a drug product in the U.S. without a valid Labeler Code.

The Labeler Code is assigned as part of the drug establishment registration process — Regovant handles the complete registration including NDC code assignment.

A Drug Master File (DMF) is a confidential submission to the FDA that provides detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of drugs.

You may need a DMF if:

• You are an API (Active Pharmaceutical Ingredient) manufacturer supplying U.S. drug companies
• You manufacture excipients, packaging materials, or equipment used in drug production
• A U.S. drug company requires it as part of their NDA/ANDA submission

Regovant prepares, submits, and maintains DMFs, and provides U.S. Agent representation for the DMF holder.

The Modernization of Cosmetics Regulation Act (MoCRA), signed into law in December 2022, represents the most significant update to U.S. cosmetics regulation in over 80 years.

Key changes that affect foreign cosmetics exporters:

• Mandatory facility registration — every cosmetics manufacturer must now register with the FDA (previously voluntary)
• Product listing — each cosmetic product must be listed with the FDA including all ingredients
• Responsible person designation — a U.S.-based responsible person must be named for each product
• Safety substantiation — products must have adequate safety substantiation on file
• Serious adverse event reporting — mandatory reporting of serious adverse events

Yes — there is a small business exemption from facility registration and product listing under MoCRA. A business qualifies if its average gross annual sales of cosmetic products in the U.S. for the previous 3 years is less than $1,000,000 (adjusted for inflation).

However, this exemption does not apply to businesses that manufacture or process:

• Cosmetics that regularly come into contact with mucous membranes of the eye
• Injected cosmetics
• Cosmetics intended for internal use
• Cosmetics intended to alter appearance for more than 24 hours

Even if exempt from registration, all cosmetics must still comply with FDA safety and labeling requirements.

Typical timelines once Regovant receives all required information from you:

• 🌿 Food Facility Registration: 3–7 business days (FDA registration number issued immediately upon submission)
• 🩺 Medical Device Establishment: 5–10 business days
• 💊 Drug Establishment + NDC: 7–14 business days
• ✨ Cosmetic Facility (MoCRA): 3–7 business days
• 📋 FCE/SID Registration: 4–8 weeks (FDA review required)
• 📁 510(k) Submission: 3–6 months (FDA review timeline)

For most registrations, we need:

• Company/facility legal name and address
• Contact person name, email, and phone number
• Type of business activities (manufacturing, packing, storage, etc.)
• Product types / categories
• Owner/operator name
• D-U-N-S number (if available — not always required)

For label reviews, you'll also need to provide the label artwork or draft label.

We send you a simple intake form after you place your order — no need to prepare anything special upfront.

Registration alone does not automatically trigger an FDA inspection. The FDA uses a risk-based system to determine which facilities to inspect, based on factors like product risk level, inspection history, and import volume.

However, the FDA does conduct routine inspections of both domestic and foreign facilities. For foreign facilities, inspections are less frequent due to logistical constraints, but they do happen — especially for high-risk product categories like drugs and certain foods.

As your U.S. Agent, Regovant will notify you immediately if the FDA requests an inspection and will assist with coordinating and preparing for it.

For most registrations, the FDA itself charges no fee. Food facility registration, medical device establishment registration, cosmetic facility registration, and drug establishment registration are all free to submit directly to the FDA.

The fees you pay to Regovant cover our professional services — gathering your information, correctly preparing and submitting the registration, managing your U.S. Agent account, and handling all ongoing FDA communications.

We accept all major payment methods through our secure checkout:

• 💳 All major credit and debit cards (Visa, Mastercard, Amex, Discover)
• PayPal
• 🏦 Bank transfer (for larger orders — contact us)

All payments are processed securely. We do not store your payment information.

FDA registration rejections are extremely rare when handled by experienced professionals. In the unlikely event that a submission is rejected or requires correction, Regovant will rework and resubmit at no additional charge.

We stand behind our work. If we cannot complete the registration for reasons within our control, we offer a full refund of our service fee.

Yes. For food facility clients with multiple locations under the same U.S. Agent agreement, we offer significantly discounted rates for each additional facility after the first.

• First facility: $795/year (full registration + U.S. Agent + Certificate)
• Each additional facility: $295/year

For large portfolios (5+ facilities or products), contact us for a custom enterprise quote.