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FDA registration, approval and private certificates
Identify what a document proves before using it for US market access.
Applicable route
An establishment registration records a facility; a listing identifies products or activities. Neither proves product approval. For a medical device, examine the applicable exemption or actual marketing decision, such as 510(k) clearance or PMA approval. For a drug, check its lawful marketing route independently of its listing.
Records and action
Food facility registration does not approve food products. Cosmetics registration and listing are not an approval programme. FDA's September 2026 clarification says it does not issue cosmetics registration, listing or exemption verification certificates. A private certificate is not an FDA decision.
Example and boundaries
Example: a seller supplies an ornate registration certificate instead of a device marketing record. Request the exact manufacturer, model, intended use and applicable decision. Do not advertise approval from the certificate. Kayra may organise this comparison; it cannot convert private paperwork into FDA authorization.
Related service guides
- FDA scope: choose the correct US product pathway
- FDA renewals: use the programme's own calendar
- FDA assessment: preparation review and regulatory inspection
- When is FDA registration required and what is exempt?
- FDA questions: supplements, cosmetics and device listings
- FDA application workflow: classify, prepare, submit and retain
- Who runs FDA registration and who decides approval?
- Choosing FDA preparation support and a US agent
- FDA required records: facility identity and product route
- FDA costs and timing: separate registration from review
Tell us what you need and our specialists will contact you.
Provide the product branch, actual facility and specific record to be prepared. Kayra can scope preparation ; no agency decision or US-agent appointment is established here.