Meta Title: FDA Registration Guide 2024 – Food, Drug, Cosmetic, Device | Legal Hub India
Meta Description: Learn everything about FDA registration for food, drug, cosmetic, and device businesses in the U.S. Step-by-step guide, requirements, and tips for successful compliance.
✅ Introduction
If you’re planning to manufacture, process, pack, or store food, drugs, medical devices, or cosmetics intended for sale in the United States, FDA registration is a crucial legal requirement. Failure to register or comply with FDA norms can result in import refusals, penalties, and even bans.
In this guide, we break down everything you need to know about FDA registration, from understanding the types of registrations to knowing how Legal Hub India can help you register smoothly with the U.S. FDA.
📘 What Is FDA Registration?
FDA registration is the process by which facilities involved in the manufacture or distribution of regulated products notify the U.S. Food and Drug Administration (FDA) of their activities. Registration allows the FDA to track, inspect, and regulate these businesses to ensure public safety.
Note: FDA registration does not mean approval. It’s a mandatory notification, not a certification or endorsement by the FDA.
🧾 Who Needs FDA Registration?
Depending on the type of business, the following entities are required to register with the FDA:
| Product Type | Who Should Register? |
|---|
| Food | Manufacturers, processors, packers, storage warehouses |
| Drugs | Manufacturers, repackers, relabelers, distributors |
| Medical Devices | Device manufacturers, sterilizers, importers, exporters |
| Cosmetics | Manufacturers, packers, distributors (as of MoCRA 2022) |
🍽️ 1. FDA Food Facility Registration (FFDCA Section 415)
Under the Federal Food, Drug, and Cosmetic Act (FFDCA), food facilities must register with the FDA if they handle food for human or animal consumption in the U.S.
Key Points:
Biennial renewal is mandatory (every even-numbered year)
Food Safety Modernization Act (FSMA) makes it compulsory for foreign facilities
A U.S. Agent is required for foreign food manufacturers
Facilities must also comply with Current Good Manufacturing Practices (cGMP)
💊 2. Drug Establishment Registration – 21 CFR Part 207
Any company that manufactures or processes drug products must register with the FDA.
Requirements:
Obtain an Establishment Registration Number (FEI)
List all drug products and ingredients
Submit Structured Product Labeling (SPL) format files
Re-registration every year between October 1 and December 31
Note: Importers must ensure overseas manufacturers are FDA-registered.
🧴 3. Cosmetic Facility & Product Listing (MoCRA)
With the passing of the Modernization of Cosmetics Regulation Act (MoCRA) in 2022, cosmetics manufacturers must now register facilities and list products.
Highlights:
Facilities must register by July 1, 2024
Renew registration biennially
Responsible Person (RP) must list all marketed products
Labeling compliance includes fragrance allergens and contact details
🩺 4. Medical Device Registration – 21 CFR Part 807
Medical device companies must register their establishments and list the devices with the FDA.
Device Classification:
Class I: General controls (e.g., thermometers)
Class II: Special controls (e.g., pregnancy test kits)
Class III: Premarket approval needed (e.g., pacemakers)
Key Requirements:
Appoint a U.S. Agent if located outside the U.S.
Pay the Device Establishment Registration Fee (updated yearly)
Register using FDA Unified Registration and Listing System (FURLS)
🖥️ FDA Registration Process: Step-by-Step Guide
Here’s how you can register your company with the FDA through its online system:
✅ Step 1: Create FURLS Account
✅ Step 2: Choose Product Category
✅ Step 3: Fill Facility Details
✅ Step 4: U.S. Agent Assignment (Foreign Companies)
✅ Step 5: Submit & Pay Fee
✅ Step 6: Receive Confirmation
⏰ FDA Registration Renewal Deadlines
| Type | Renewal Cycle | Deadline |
|---|
| Food Facilities | Biennial | Dec 31 (even years) |
| Drug Establishments | Annual | Oct 1 – Dec 31 |
| Medical Devices | Annual | Dec 31 |
| Cosmetics (MoCRA) | Biennial | TBD (starting 2024) |
Missing a deadline can lead to deactivation or refusal of product entry.
⚠️ Common Mistakes to Avoid
Incorrect Facility Details – Results in delays or refusal
No U.S. Agent – Foreign facilities must appoint a U.S. contact
Missing Renewals – FDA cancels expired registrations
Unlisted Products – Products must be listed individually
Assuming FDA “Approval” – Registration ≠ Approval
📈 Benefits of FDA Registration
✅ Legal Compliance
✅ Market Access to the U.S.
✅ Easier Customs Clearance
✅ Higher Trust & Credibility
✅ Essential for Amazon/Online Sales
✅ Facilitates FDA Inspection Compliance
💼 How Legal Hub India Can Help
At Legal Hub India, we offer complete support in FDA registration:
✔️ Application Filing
✔️ U.S. Agent Representation
✔️ Label Review & Compliance
✔️ Product Listing
✔️ Annual Renewals & Monitoring
✔️ Regulatory Consultation
We’ve helped dozens of Indian exporters get FDA-registered and access Amazon, Walmart, and U.S. retailers.
🔍 SEO Tips for WordPress Post
When publishing this article on WordPress, keep the following SEO practices in mind:
| Task | Tip |
|---|
| Title Tag | Include “FDA Registration 2024” |
| Meta Description | Keep it under 160 characters with CTA |
| Headings (H1–H3) | Use for structure and keyword clarity |
| Image Alt Text | Describe images with keywords |
| Internal Linking | Link to related services or blogs |
| URL Slug | Use /fda-registration-guide |
| Featured Image | Add a visual of FDA certificate or workflow |
| Mobile Optimization | Use responsive themes |
| Last Updated Tag | Add dynamic “Updated on [date]” field |
🧾 Conclusion
FDA registration is non-negotiable if you want to sell or export your products in the United States. Whether you’re in food, pharma, cosmetics, or devices, registering your facility with the FDA ensures compliance, access, and long-term credibility.
Let Legal Hub India be your trusted partner in navigating the complexities of FDA registration—from start to finish.
📥 Ready to Start?
Contact us today to get FDA registration assistance from industry experts. Call +91-XXXXXXXXXX or visit www.legalhubindia.com
