Frequently Asked Questions (FAQ)
FDA Registration Assistance – All Services
This FAQ page provides detailed answers to common questions about FDA registrations, listings, compliance services, and regulatory requirements across food, drugs, medical devices, cosmetics, and imports. If you don’t see your question answered below, please contact us directly.
GENERAL QUESTIONS
What is FDA Registration Assistance?
FDA Registration Assistance is an independent FDA regulatory consulting firm that helps domestic and foreign companies comply with U.S. Food and Drug Administration requirements. We assist with registrations, listings, labeling reviews, compliance documentation, and ongoing regulatory support.
Are you affiliated with the FDA?
No. FDA Registration Assistance is not affiliated with, endorsed by, or part of the FDA. We are a private consulting firm that helps clients meet FDA regulatory requirements.
Who do you work with?
We work with:
Manufacturers
Importers
Brand owners
Amazon sellers
Distributors
Startups and established companies across food, dietary supplements, drugs, medical devices, and cosmetics.
Do you work with international companies?
Yes. We work with clients worldwide seeking to sell FDA-regulated products in the United States.
Can you guarantee FDA approval or clearance?
No. No consultant or third party can guarantee FDA approval, clearance, or inspection outcomes. We provide compliance guidance and accurate submissions based on FDA regulations.
FOOD FACILITY REGISTRATION & FOOD COMPLIANCE
Who needs FDA Food Facility Registration?
Any domestic or foreign facility that manufactures, processes, packs, or holds food for consumption in the United States must register, unless exempt.
How often does FDA Food Facility Registration need to be renewed?
Food facility registration must be renewed every even-numbered year between October 1 and December 31.
Do warehouses and storage facilities need to register?
Yes. Facilities that hold food, including warehouses and storage facilities, must register.
What is FDA Prior Notice?
Prior Notice is an advance electronic notification required for all food and animal feed imported into the U.S.
Can you file Prior Notice for my shipments?
Yes. We provide FDA Prior Notice filing services to ensure shipments are not delayed or refused.
What is FSVP?
The Foreign Supplier Verification Program (FSVP) requires importers to verify that foreign suppliers produce food that meets U.S. safety standards.
Do Amazon food sellers need FSVP?
Yes. Many Amazon sellers importing food or dietary supplements must have an FSVP plan and may need an FSVP Agent.
HACCP & FOOD SAFETY PLANS
What is a HACCP Plan?
A HACCP Plan is a preventive food safety system that identifies and controls biological, chemical, and physical hazards.
What is a Food Safety Plan (FSP)?
A Food Safety Plan is required under FSMA and includes hazard analysis, preventive controls, monitoring, corrective actions, and verification.
Who is a PCQI?
A Preventive Controls Qualified Individual (PCQI) is responsible for developing or overseeing a Food Safety Plan.
Can you create or review HACCP and Food Safety Plans?
Yes. We create, review, and update HACCP Plans and Food Safety Plans.
DRUG ESTABLISHMENT REGISTRATION & DRUG SERVICES
Who must register as a Drug Establishment?
Any domestic or foreign facility that manufactures, repacks, or relabels drug products for the U.S. market.
How often is Drug Establishment Registration required?
Drug establishments must register annually between October 1 and December 31.
What is Drug Listing?
Drug listing is the process of submitting product-specific information to the FDA for each marketed drug.
What is a Labeler Code?
A Labeler Code is a 5-digit code assigned by FDA that forms the first segment of the NDC number.
What is an NDC Number?
The National Drug Code (NDC) uniquely identifies drug products and consists of labeler, product, and package codes.
Do you assist with DMFs?
Yes. We assist with Drug Master File (DMF) preparation, submission, and maintenance.
Does FDA approve DMFs?
No. DMFs are neither approved nor disapproved and are reviewed only when referenced.
MEDICAL DEVICE REGISTRATION & COMPLIANCE
Who must register as a Medical Device Establishment?
Any establishment involved in manufacturing, assembling, processing, or distributing medical devices for the U.S.
How often is Medical Device Establishment Registration required?
Medical device establishments must register annually and pay the FDA user fee.
What is Medical Device Listing?
Medical Device Listing identifies the generic category and product codes for devices being marketed.
Does listing mean FDA approval?
No. Listing is not approval or clearance.
What is a 510(k)?
A Premarket Notification (510(k)) demonstrates that a device is substantially equivalent to a legally marketed device.
Can you review medical device labeling?
Yes. We review labeling for compliance with 21 CFR Part 820 and FDA requirements.
What is a U.S. FDA Agent for medical devices?
A U.S. FDA Agent is required for foreign medical device establishments and serves as FDA’s point of contact.
COSMETICS & MOCRA
What is MoCRA?
MoCRA is the Modernization of Cosmetics Regulation Act of 2022, the largest update to U.S. cosmetic law.
Who must register under MoCRA?
Any facility that manufactures or processes cosmetic products distributed in the U.S.
What is MoCRA Product Listing?
MoCRA Product Listing requires cosmetic products to be listed with the FDA, including ingredient and product details.
Do you assist with MoCRA compliance?
Yes. We assist with:
MoCRA Facility Registration
MoCRA Product Listing
Cosmetic labeling review
Ingredient compliance
What is CSCAR?
California Safe Cosmetics Act Reporting (CSCAR) is a California-specific requirement for reporting certain cosmetic ingredients.
Is CSCAR separate from MoCRA?
Yes. CSCAR is a California state requirement, separate from FDA requirements.
DUNS NUMBER & FACILITY IDENTIFICATION
What is a DUNS Number?
A DUNS Number is a 9-digit identifier used by FDA to identify physical facility locations.
Who needs a DUNS Number?
DUNS Numbers are required for:
Food facilities
Drug establishments
Medical device establishments
Cosmetic facilities (MoCRA)
Do multiple facilities need multiple DUNS Numbers?
Yes. Each physical location needs its own DUNS Number.
Can you help obtain a DUNS Number?
Yes. We provide DUNS Request Assistance for all FDA-regulated industries.
LABELING & INGREDIENT REVIEW
Do you review food labels?
Yes. We review food labels for FDA compliance, including Nutrition Facts, allergens, and claims.
Do you review cosmetic labels?
Yes. We review cosmetic labels for FDA and MoCRA compliance, including INCI ingredient names.
Do you review OTC drug labels?
Yes. We review OTC labels for Drug Facts Panel compliance.
Does FDA approve labels?
No. FDA does not pre-approve most labels, but non-compliance can result in enforcement action.
CERTIFICATES
Does the FDA issue certificates?
No. The FDA does not issue or recognize certificates.
What are your certificates used for?
Our certificates are informational documents summarizing existing FDA registrations or listings.
Who is eligible for certificates?
Certificates are issued only to clients with completed and active registrations or listings.
WORKING WITH FDA REGISTRATION ASSISTANCE
How long does the process take?
Timelines vary by service, but many registrations and filings can be completed within a few business days.
Is my information confidential?
Yes. All client information is treated as confidential.
How do I get started?
Contact us with your product or facility details, and we’ll guide you step-by-step.
