U.S. FDA Agent

U.S. FDA Agent for foreign medical-device and IVD establishments

CENIT acts as the U.S. FDA Agent for foreign medical-device and IVD establishments. The role is the U.S. contact for FDA communication and inspection coordination under 21 CFR 807.40.

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Annual plans from $329 for medical-device and IVD establishments. For other U.S. FDA Agent needs, see Food U.S. FDA Agent or MoCRA Cosmetics U.S. FDA Agent.

U.S. FDA Agent Services

Need Food Facility or MoCRA Cosmetics support?

This page is for Medical Device / IVD U.S. FDA Agent support. If your company needs Food Facility Registration or MoCRA Cosmetics U.S. FDA Agent support, use the dedicated service pages below.

Not sure which service fits? Contact CENIT before paying.

Packaged food products beside registration paperwork

Food U.S. FDA Agent

For foreign food facilities that need FDA registration and U.S. Agent support.

View Food U.S. FDA Agent
Cosmetics products beside regulatory documentation

MoCRA Cosmetics U.S. FDA Agent

For cosmetics facilities that need MoCRA facility registration and U.S. Agent support.

View MoCRA U.S. FDA Agent

Fit check

Do you need a U.S. FDA Agent?

Foreign establishments that register and list medical devices with FDA must identify a U.S. Agent. The role is a U.S. communication contact for FDA, including inspection-related communication.

You may need this service if

  • Your medical-device or IVD establishment is outside the United States.
  • You register and list with FDA.
  • FDA needs a U.S. contact for communication or inspection coordination.
  • You want U.S. Agent appointment handled with clear scope and annual support options.

Use a separate service if

  • Your establishment is based in the United States.
  • You only need submission strategy, QMS support, or regulatory writing.
  • You need an importer, distributor, commercial representative, or legal representative.
  • You manufacture cosmetics and need MoCRA support.
  • You need food facility registration or food U.S. Agent support.

Based in the U.S.? You typically do not need a U.S. FDA Agent. Ask CENIT which plan fits

Role scope

What CENIT covers

The U.S. FDA Agent role is narrow. That is useful when the responsibilities are clear before payment.

Included in the U.S. Agent role

  • U.S. FDA Agent appointment for a foreign establishment.
  • FDA communication contact for the registered establishment.
  • Inspection communication liaison.
  • Notice forwarding within 1 business day of FDA-addressed communication received during U.S. business hours.
  • Appointment details needed for FDA registration records.

Not included unless separately scoped

  • 510(k), De Novo, PMA, or other submission preparation.
  • Market clearance, approval, or authorization.
  • Quality-system responsibility.
  • Legal representation.
  • Importer, distributor, or commercial representative duties.
  • Cosmetics/MoCRA support.
  • Food facility registration or food U.S. Agent support.

Plans

Choose the U.S. FDA Agent plan

Lite is for Agent appointment only. Core adds Official Correspondent and annual FDA admin support. Plus adds onboarding and advisory time.

Lite

U.S. FDA Agent appointment

$329/year

For foreign establishments that need CENIT named as U.S. FDA Agent and have registration/listing administration handled elsewhere.

Includes

  • U.S. FDA Agent appointment.
  • FDA communication contact.
  • Inspection communication routing between FDA and your establishment.
  • FDA-addressed notice forwarding within 1 business day of receipt during U.S. business hours.
  • Annual confirmation letter documenting CENIT as your U.S. FDA Agent of record.

Does not include Official Correspondent support, annual registration/listing administration, scheduled calls, or live advisory time.

Choose Lite - $329/year
Best value Core

Agent + annual FDA admin support

$725/year

For companies that want U.S. Agent appointment, Official Correspondent support, and annual registration/listing assistance in one service.

Includes

  • Everything in Lite.
  • Official Correspondent support.
  • Annual registration/listing assistance.
  • 1 hour of advisory time on Agent, Official Correspondent, registration, listing, or onboarding questions.
  • Renewal reminder.

Advisory time does not include submission strategy, submission writing, or QMS work unless separately scoped.

Choose Core - $725/year
Plus

Agent + annual support + onboarding help

$1,350/year

For companies that also need advisory time for UDI, eMDR, or related FDA onboarding questions.

Includes

  • Everything in Core.
  • 3 hours of advisory time on Agent, Official Correspondent, registration, listing, or onboarding questions.
  • UDI/eMDR onboarding questions.
  • Prioritized handover support.

Advisory time does not include submission strategy, submission writing, or QMS work unless separately scoped.

Choose Plus - $1,350/year
Not sure which plan fits? Send the question first Book a 30-minute fit call

Switch savings: 15% off year 1 when moving from another U.S. FDA Agent. Available through December 31, 2026 with discount code SWITCHAGENT at checkout.

How the service starts

Secure payment, receipt for records, guided intake, CENIT confirms the next step before FDA filing support begins, and FDA filing is not FDA approval.

Role clarity

U.S. FDA Agent and Official Correspondent are different roles

The U.S. FDA Agent is the U.S. contact for FDA communication and inspection coordination for a foreign establishment. The Official Correspondent is tied to FDA registration and listing administration.

Lite

Lite covers U.S. FDA Agent appointment and FDA-addressed notice forwarding.

Core and Plus

Core and Plus include Official Correspondent support and annual registration/listing assistance. Plus adds more advisory time for onboarding questions.

Options

Compare U.S. FDA Agent options

The cheapest option is not always the clearest option. Buyers should know who receives FDA communication, how notices are forwarded, and whether Official Correspondent and registration/listing support are included.

CENIT U.S. FDA Agent plans

  • Public annual pricing.
  • FDA-addressed notices forwarded within 1 business day during U.S. business hours.
  • Lite, Core, and Plus plan boundaries published before payment.
  • Official Correspondent support included in Core and Plus.

Distributor or broad FDA provider

  • Commercial dependency and role boundaries may be less clear.
  • Device/IVD scope, Official Correspondent support, and advisory boundaries should be confirmed before payment.
  • If you need broad FDA support outside device/IVD Agent duties, ask before choosing a plan.

Questions

Ask before you choose a plan

Use this before payment when the right plan is unclear, when you are switching agents, or when the question may belong to cosmetics/MoCRA or food instead.

Before you choose

Send enough context for CENIT to confirm whether this is the right service before you pay.

What to include

  • Device or IVD type.
  • Current FDA registration/listing status.
  • Whether you need Official Correspondent support.
  • Whether the request may be cosmetics/MoCRA or food.

What CENIT confirms

  1. Which plan fits, if any.
  2. Whether anything needs a separate scope.
  3. Whether to pay online or book a short fit call.

Send your question

Ask about plan fit, switching agent, Official Correspondent support, registration/listing scope, or whether the request belongs under cosmetics/MoCRA or food.

FAQ

Questions about U.S. FDA Agent appointment

A few common scope questions before you choose a plan.

Who needs a U.S. FDA Agent?

Foreign establishments that register and list medical devices with FDA must identify a U.S. Agent. The U.S. Agent serves as a U.S. contact for FDA communication and inspection coordination.

Is the U.S. FDA Agent the same as the Official Correspondent?

No. Lite is for U.S. Agent appointment only. Core and Plus include Official Correspondent support.

Does CENIT handle FDA registration and listing?

Core and Plus include annual registration/listing assistance. Lite does not include registration/listing administration.

Does this include 510(k), De Novo, or PMA submissions?

No. Submissions are not included in the U.S. FDA Agent plans. Submission work can be scoped separately.

Can I switch from another U.S. FDA Agent?

Yes. CENIT can support a switch once the establishment and contact information needed for the update is complete.

Appoint CENIT as U.S. FDA Agent

Choose a plan online, ask a question first, or book a fit call if scope needs to be confirmed.

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