FDA US agent: separate appointment, registration and product authorisation
Use this guide to separate an agent communication service from establishment registration and product authorisation work. Confirm the foreign establishment, its activities and the applicable registration provisions before deciding that an appointment is required. A product route or 510(k) submission is a separate assessment, not an automatic consequence of hiring an agent. The acquired 21 CFR 807.40 connects a foreign device establishment’s registration information with its one US agent. The agent helps FDA communicate, answer questions and schedule inspections. Section 807.39 separately states that establishment registration does not denote approval of the establishment or its products. Assess the product’s regulatory route independently.
Evidence retrieved 2026-10-06. Source versions and topic-specific limits are listed below.
Sourced criteria · US
What changes the service scope?
Decision or task
What the source describes
What to prepare
Which establishment and activity is involved?
Section 807.40(a) addresses specified foreign device-manufacturing/processing establishments whose devices are imported or offered for import. [1]
Confirm the actual establishment and activity, covered products and applicable registration provisions.
Agent or official correspondent?
Paragraph (b) specifies one US agent and permits that agent also to act as official correspondent; paragraph (a) describes the correspondent’s communication role. [1]
Allocate the appointment and registration-account work explicitly; check US residence/place of business.
What service should be included?
Paragraph (b)(2) addresses FDA communications, questions on imported products and inspection scheduling assistance. [1]
Ask who receives authority contact, who answers product questions and how management is reached.
How are changes and listings handled?
Paragraphs (b)(3), (c) and (d) describe change reporting, registration/listing context, an investigational-use exception and English information. [1]
Create a controlled update workflow and assess the actual product authorisation separately.
Does registration establish approval?
Section 807.39 says establishment registration does not denote approval of the establishment or its products and addresses misleading representations of official approval. [2]
Keep registration evidence separate from product authorisation and review how status is described publicly.
Device route, registration applicability and establishment facts remain incomplete. Neither a register entry nor this appointment is approval, clearance or a provider accreditation.
US agent appointment and separate product-route assessment
Use this checklist to gather your business or product details before speaking with a specialist. The items below explain what to record and suggest useful supporting documents. You can add your own answers in the editable project brief.
Which establishment and activity is involved?
Confirm the actual establishment and activity, covered products and applicable registration provisions.
Useful evidence: Establishment legal name/address, activities and device portfolio.
Conditional: US agent appointment and communication scope — Preparation tasks to agree: Confirm the actual establishment and activity, covered products and applicable registration provisions. Allocate the appointment and registration-account work explicitly; check US residence/place of business. Ask who receives authority contact, who answers product questions and how management is reached. Create a controlled update workflow and assess the actual product authorisation separately. Keep registration evidence separate from product authorisation and review how status is described publicly. This package remains conditional until the deciding facts and exclusions are agreed.
Optional: Separate device-route and submission evidence assessment — Separately assess separate device-route and submission evidence assessment. Include it only when the actual product route and evidence gaps justify it; the primary appointment does not establish this additional requirement.
Questions for providers
Which exact actor, product or processing facts support the quoted scope, and what is still unresolved?
How will the listed records reach the responsible people, and who owns each change or authority request?
Which tasks and entities are excluded from the agreement, and which additional services need a separate assessment?
Sources and data dates
Read the official document in context. The audit details identify the precise locators and preserved versions used for this page.
