Food, spices, packaged foods, medical devices, pharmaceuticals and cosmetics cannot enter the US unless the manufacturing facility is registered with the U.S. Food and Drug Administration (FDA) and a US Agent is named. Some products also need pre-market clearance. Missing or expired registration is one of the most common reasons Indian shipments are detained at US ports. Global Approbation handles registration, listings and renewals so your exports keep moving.
FDA Requirements by Product Type
| Food & beverages, spices, supplements | Food Facility Registration (renewed every even-numbered year, 1 October to 31 December) · US Agent · Prior Notice before each shipment · labelling to US rules · FSMA preventive-controls expectations |
|---|---|
| Medical devices & IVDs | Establishment Registration & Device Listing (renewed annually, with an FDA user fee) · US Agent · device classification · 510(k), De Novo or PMA where required · Quality Management System Regulation (QMSR), aligned with ISO 13485 |
| Cosmetics & personal care | Facility registration and product listing under MoCRA (Modernization of Cosmetics Regulation Act 2022) · labelling and safety substantiation · adverse-event reporting readiness |
| Drugs & APIs | Drug Establishment Registration · Drug Listing / NDC · US Agent · DUNS number · cGMP readiness |
| Radiation-emitting electronics (lasers, some LED/UV products) | Product reports / accession numbers under FDA CDRH radiological health rules |
What Global Approbation Does
- Product classification and a clear list of FDA obligations for each product
- FDA account setup, facility registration and product listings
- US Agent service coordination and DUNS number assistance
- US label review (nutrition facts, allergen, device and cosmetic labelling)
- 510(k) strategy and submission support for medical devices
- Renewal reminders and handling of FDA import detentions or refusals
How the Process Works
- Classification. We confirm how the FDA regulates your product (food, device class, cosmetic, drug).
- US Agent & identifiers. US Agent confirmed, DUNS obtained or verified.
- Registration & listing. Facility registered and products listed in the correct FDA system.
- Pre-market steps. 510(k) or other submissions where the product requires them.
- Shipment readiness. Labels, Prior Notice (food) and importer documents checked before dispatch.
FDA: Frequently Asked Questions
Does FDA “approve” or “certify” my product?
Usually not. For most food, cosmetics and many devices, FDA requires registration and listing, not an approval certificate. Be cautious of anyone selling “FDA certificates”: FDA does not issue registration certificates. Pre-market clearance (510(k)) or approval applies only to certain devices and drugs.
When does food facility registration need renewing?
Food facility registrations must be renewed every even-numbered year between 1 October and 31 December. 2026 is a renewal year, so registrations not renewed by 31 December 2026 are treated as expired.
Why do I need a US Agent?
Foreign facilities registering with FDA must designate a US Agent who is physically in the United States and acts as the communication link with FDA. Your importer can act as US Agent, or a professional US Agent service can be used.
Does my Indian FSSAI or CDSCO licence help?
A CDSCO or FSSAI licence shows regulatory maturity and supports your documentation, but it does not replace FDA registration. US requirements such as labelling, device classification and QMSR expectations must be met separately.
Regulations, standards and deadlines change. Scope, testing route and timelines are confirmed product by product after our applicability review. Global Approbation is a consultancy and does not itself issue certificates; approvals are granted by the relevant authority, accredited laboratory, certification body or notified body.