US FDA registration and compliance for Indian exporters.
Food, supplements, cosmetics, drugs and medical devices all need the right FDA registration before shipping to the US. We register your facility, act on US Agent arrangements, file listings and Prior Notice, review labels and keep renewals on time, including the October–December 2026 food renewal.
What FDA compliance involves
Registration
Facility registration and product listing in FDA’s systems, with a US Agent for foreign sites.
Shipment Filings
Prior Notice for food shipments and correct entry data at the port.
Product Rules
Labelling, GMP and, for drugs and devices, clearance or approval where required.
US FDA compliance: the key facts
| Food | Facility registration renewed 1 Oct – 31 Dec of even years (2026 is a renewal year); Prior Notice per shipment |
| Cosmetics | MoCRA facility registration and product listing; biennial renewal |
| Drugs | Establishment registration and drug listing, renewed annually; NDC |
| Devices | Annual establishment registration (FY 2027 fee US$13,785); listing; 510(k)/De Novo/PMA where required; QMSR from 2 Feb 2026 |
| All foreign facilities | US Agent required |
| Consultant | Bizpro Compliance Services, New Delhi, handles export and buyer-driven certifications (FCC, FDA, HACCP, Halal, AIOTA, Organic and RoHS) for Indian manufacturers and exporters, working with accredited labs and certification bodies: +91 920 500 6364, contact@bizprocompliance.com |
What US FDA requires for your product
FDA requirements depend on the product type. Find yours to see the registration and filings needed.
Showing all 8 product types
| No. | Product Type | FDA Requirement | Type | |
|---|---|---|---|---|
| 1 | Food & BeveragesProcessed foods, spices, snacks, beverages | Food facility registration (renew Oct–Dec in even years), US Agent, Prior Notice per shipment, FSMA rules | Registration | |
| 2 | Low-Acid & Acidified Canned FoodsRetorted and acidified foods | Food canning establishment (FCE) registration and process filings (SID) | FCE / SID | |
| 3 | Dietary SupplementsHerbal, nutraceutical and ayurvedic supplements | Food facility registration; supplement labelling and cGMP | Registration | |
| 4 | CosmeticsSkincare, haircare, personal care | MoCRA facility registration (biennial renewal) and product listing | MoCRA | |
| 5 | OTC & Prescription DrugsManufacturers and APIs | Drug establishment registration and listing (annual), NDC, GMP | Registration & listing | |
| 6 | Medical DevicesClass I, II and III devices | Establishment registration (annual fee), device listing, 510(k) / De Novo / PMA or exemption, QMSR | Registration & listing | |
| 7 | US AgentForeign food, drug and device facilities | Mandatory US Agent for foreign facilities | Required | |
| 8 | Labelling ReviewNutrition facts, ingredients, allergens, claims | Label compliance before export | Recommended |
“” isn’t in this list
Tell us the product and target market or tender, and we’ll confirm exactly which certification and route applies.
Tell us what the product is and we’ll confirm which approvals it needs, free.
Sources: the regulators’ and scheme owners’ published rules and notices (FCC, US FDA, Codex, DGFT / QCI, APEDA / NPOP, FSSAI, EU), and tender documents, checked on 1 November 2026.
Get your FDA compliance quote and timeline
Tell us the product, target market or buyer, and your current certificates. A specialist confirms the route, testing or audit, total cost and timeline, in writing.
- Reply within one business dayFrom a named consultant, not an automated sales sequence.
- Fixed written quoteGovernment fees, lab charges and our fee listed separately before you commit.
- Accredited labs & bodiesTesting and audits only where the result will be accepted.
What FDA compliance costs
FY 2027 device establishment registration fee is US$13,785, due by 31 December 2026.
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Your FDA compliance step by step
We start from the market or buyer requirement, so you only pay for what will be accepted.
Requirement Check
Target market, buyer or tender requirement confirmed, with the exact standard or rule.
Day 1–2Gap Assessment
Product, facility or documents checked against the requirement.
Week 1Registration & Listing
Facility registered, US Agent confirmed, products listed.
Week 1–2Labels & Filings
Labels reviewed; Prior Notice, clearance or approvals planned.
Week 2–4Certificate & Upkeep
Certificate or registration issued; renewals, surveillance and changes tracked.
OngoingExport certifications for manufacturers across India
We coordinate testing, audits and registrations for exporters and manufacturers in every state, including major export hubs:
Common mistakes
Missed Renewal
An unrenewed food facility registration is treated as expired.
Non-Compliant Labels
Label errors, especially allergens, are a leading cause of import refusals.
No Prior Notice
Food shipments without Prior Notice are held at the port.
Assuming Registration = Approval
Devices and drugs may need clearance or approval as well.
Other certifications your buyers may ask for
ISO 13485
Medical device QMS for FDA QMSR. See ISO 13485.
FCC Certification
US equipment authorisation for electronics. See FCC Certification.
HACCP Certification
Food safety system for export buyers. See HACCP Certification.
Halal Certification
Food, meat and consumer goods for halal markets. See Halal Certification.
AIOTA Certification
Ergonomic evaluation for furniture tenders. See AIOTA Certification.
Organic Certification
NPOP, PGS-India and export organic certification. See Organic Certification.
Common questions about US FDA registration and compliance
Do Indian food exporters need FDA registration?
Is 2026 a food facility renewal year?
Is FDA registration the same as FDA approval?
What is MoCRA for cosmetics?
What does FDA charge for medical device registration?
Does FDA accept ISO 13485 for devices?
What is a US Agent?
Get export-ready before you ship
Tell us your product and target market or tender. We’ll confirm the certification, route, cost and timeline in writing, free.