FDA notices → 1 business day Foreign establishments only Devices & IVD

U.S. FDA Agent for Medical Devices & IVD

Appoint CENIT as your U.S. FDA Agent — Today. Select the right plan for your establishment.

  • Liaison-only under 21 CFR § 807 — forwarding FDA-labeled notices fast
  • Inspection coordination with your team
  • Switch from your current agent in ~48 hours. And get 15% discount year 1.
Get Lite — $329/yr Compare Plans
Prefer more help? Core — $725/yr • Plus — $1,350/yr
1 DayFDA Notice Response
Business day turnaround
48 hrsAgent Switch
No registration downtime
100%Devices & IVD Focus
Specialized expertise
ClearScope & Pricing
No hidden fees

U.S. FDA Agent — what you get

Clear scope, fast onboarding, and an experienced team focused on medical devices and IVDs.

Devices & IVD

We partner with medical device and IVD manufacturers (foreign establishments) operating under 21 CFR § 807. If you need an experienced U.S. Agent to keep FDA communications smooth and timely, you're in the right place.

Included — your U.S. Agent, handled by specialists
  • Liaison role per 21 CFR § 807.3 for foreign establishments
  • Rapid notice handling — FDA-addressed communications received and forwarded within 1 business day
  • Inspection coordination — scheduling support and logistics with your team
  • Availability during U.S. hours with clear, documented SLAs
Optional add-ons

Bundle as needed based on your compliance requirements and internal capacity.

Available with Core & Plus plans
  • Official Correspondent (OC) responsibilities and correspondence tracking
  • Registration & listing admin (FURLS/DRLM updates, annual confirmations)
  • GUDID/eMDR onboarding and UDI implementation support
  • Regulatory advisory and project packages (510(k), De Novo, Q-Sub, strategy)
Is this a fit?
Foreign establishment You are a non-U.S. device/IVD establishment selling into the U.S.
Agent required You require a designated U.S. Agent for FDA communications & inspections.
Not U.S.-based? Based in the U.S.? You typically do not need a U.S. Agent.
See Pricing
Transparent scope, predictable SLAs, and fast onboarding.

Simple pricing, clear scope

Pick the level of involvement you need. Upgrade anytime.

Lite
Essential U.S. Agent
$329/yr
Best for straightforward FDA liaison needs.
Includes
  • U.S. Agent (liaison-only) per 21 CFR § 807.3
  • Forward FDA-labeled notices within 1 business day
  • Assist with inspection scheduling
  • Email support (no scheduled calls)
  • One contact change/year included
Not in Lite
  • Regulatory advice or submissions
  • Official Correspondent (OC)
  • Registration/listing admin, GUDID, eMDR
Get Lite — $329/yr
Secure checkout
Best value
Core
Agent Core
$725/yr
Adds OC and yearly admin support.
Includes
  • Everything in Lite
  • Official Correspondent (OC)
  • Next-business-day SLA on all tickets
  • Annual registration/device-listing admin
  • 1 consulting hour/year
Not in Core
  • GUDID Regulatory Contact
  • eMDR Account-Owner setup
  • Large UDI projects
Get Core — $725/yr
Secure checkout
Plus
Agent Plus
$1,350/yr
Complete bundle for UDI & eMDR onboarding.
Includes
  • Everything in Core
  • GUDID Regulatory Contact
  • eMDR Account-Owner setup
  • UDI bundle (≤ 10 DIs)
  • +3 consulting hours
Not in Plus
  • Mass UDI uploads (>10 DIs)
  • 510(k)/De Novo/PMA submissions
  • Complex regulatory submissions
Get Plus — $1,350/yr
Secure checkout
Need mass UDI or 510(k)/De Novo/PMA help? We offer this as a separate service — see services.

What’s included in each plan

Clear scope so you know exactly what you're getting—and what isn't included.

FeatureLiteCorePlus
U.S. Agent (liaison-only)
Forward FDA notices in 1 business day
Official Correspondent (OC)—
Registration/listing admin (annual)—
GUDID Regulatory Contact——
eMDR Account-Owner setup——
UDI bundle (≤ 10 DIs)——

Compare your options

See how CENIT stacks up against common alternatives.

CriteriaCENITDistributor as AgentGeneric agencyIn-house rep
Forwarding SLA (FDA-labeled) 1 business day Varies Varies Coverage gaps
Scope clarity (Agent vs OC vs consulting) Clear, plan-based Conflicted priorities Often unclear Depends on role
Switch-in speed ~48 hours Slow/varies Varies N/A
OC & annual admin available Core / Plus Rare Sometimes Inconsistent
GUDID & eMDR onboarding Plus No Depends No
Independence (no sales conflict) Yes Conflicts likely Varies N/A
Comparisons are generalized to help evaluation; confirm your needs and scope.
15% off year-1 when switching

Switch to CENIT in 48 hours

Move from your current U.S. Agent (and Official Correspondent) to CENIT with no disruption to your FDA registration.

Checkout & agree
Subscribe to Lite / Core / Plus and accept terms (≈2 minutes). If you're switching from another agent, your year-1 discount applies. Use discount code SWITCHAGENT when checking out.
Short intake
Complete a 3–5 minute form with company + establishment details (FEI, owner/operator) and your current agent/OC so we can prepare the change.
Designate in FURLS
We send one-click instructions to assign CENIT as your U.S. Agent (and OC for Core/Plus) in FURLS → DRLM. Prefer hands-off? We can file the change for you for +$150.
Confirmation
We verify the change in FURLS and issue your Agent letter. Your FEI, owner/operator and device listings stay the same—only the FDA contact changes.
What “switch in 48 hours” means — and why it helps
No downtime
From: your current U.S. Agent/OC → To: CENIT as the FDA-facing contact for your establishment.
  • No downtime: registration and listings remain active during the change.
  • Faster response: FDA-labeled notices forwarded within 1 business day (Core/Plus includes priority handling).
  • Lower admin load: Core/Plus includes annual registration/listing admin; Plus adds GUDID/eMDR onboarding.
  • Switch savings: 15% off year-1. Use discount code: SWITCHAGENT
Timeline assumes intake completed and FURLS access provided during U.S. business hours.
FAQ

Clear answers on U.S. Agent & OC

Quick, practical guidance on designations, onboarding timelines, and what’s included across plans.

? Do we still need a U.S. Agent if we have a distributor?
Yes. Non-U.S. establishments must designate exactly one U.S. Agent. A distributor can serve as the Agent, but many companies prefer an independent contact to keep responsibilities clear and avoid conflicts.
i U.S. Agent vs Official Correspondent (OC)?
The U.S. Agent is a liaison for FDA communications and inspection coordination. The Official Correspondent (OC) is the administrative contact of record for your FDA registration and device listing. OC is included in Core and Plus.
✓ What admin is included in Core?
Routine annual registration/device-listing updates and confirmations (admin scope). It doesn’t include regulatory strategy or submissions (e.g., 510(k), De Novo, PMA).
+ What does Plus add?
GUDID Regulatory Contact, eMDR Account-Owner setup, a small UDI bundle (≤ 10 DIs), plus 3 consulting hours. It’s the simplest way to stand up UDI/eMDR with minimal internal effort.
– Do you give advice at Lite?
Lite is liaison-only. For advice, add consulting or choose Core/Plus.
↦ How fast is onboarding?
Most switch-ins complete in about 48 hours after payment and intake. We provide your Agent letter and FURLS steps—or we can file the change for +$150.
☎ Phone support?
We answer our U.S. phone for FDA calls during U.S. business hours. Lite uses email and phone support is included with Core/Plus.
$ Billing & renewals?
Annual subscription via Stripe (through HubSpot Payments) with auto-renew. We send renewal reminders in advance.
? Who is required to appoint a U.S. FDA Agent?
Foreign medical device, IVD, and combination product establishments selling in the U.S. must appoint a U.S. Agent—regardless of company size or existing U.S. partnerships.
i Can CENIT act as both U.S. Agent and Official Correspondent (OC)?
Yes. Our Core and Plus plans include OC support for all FDA establishment registration and device listing communications.
✓ What documentation do I need to switch to CENIT as my FDA Agent?
FEI/establishment number, current/prior agent details, and company contact information. We supply a pre-filled appointment letter and step-by-step FURLS instructions.
↦ Is it possible to switch FDA agents mid‑year?
Yes. You can appoint or change agents at any time (not only during renewal) with no service interruption when coordinated properly.
+ Does CENIT provide eMDR and UDI onboarding for medical device companies?
Yes. eMDR/UDI account setup, GUDID registration, and a Device Identifier mini‑bundle are included in Plus, with tailored support for other tiers.
☎ How does CENIT handle urgent FDA notifications after‑hours or on holidays?
We monitor compliance channels continuously. Priority and Plus clients receive expedited forwarding and escalation regardless of local office hours.
? What happens if an FDA notice goes to my old agent?
We coordinate with your prior agent to close the loop, and issue immediate confirmation and proof‑of‑appointment for FDA records.
$ How do I renew my service or update establishment details?
Renewal is automatic with advance reminders. Update company/address/registration information anytime via by email.
✓ Is on‑site inspection support offered?
Yes. We notify you of scheduled inspections and can add remote or on‑site readiness support as an optional service.
+ Are there consulting add‑ons for FDA submissions (510(k), PMA, De Novo)?
Yes. Full regulatory, quality, and compliance consulting—including 510(k), labeling, and QMS—is available through CENIT Consulting.
i How does CENIT ensure the security and privacy of my FDA submission data?
Data is handled under GDPR and U.S. privacy standards with encrypted channels and regulatory‑grade security practices.
✓ Can you act as U.S. Agent for Class I, II, and III medical devices?
Yes. We support all device classes with onboarding tailored to risk profile and regulatory pathway.
i Does the U.S. Agent service cover FDA food, cosmetics, or pharma?
Our primary expertise is medical devices and IVD. Contact us for cross‑sector U.S. Agent or OC needs.
+ Can I appoint CENIT as U.S. Agent for more than one establishment or affiliate?
Yes. Multi‑entity onboarding is supported with bundled pricing. Contact us for a group quote.
Glossary

Key definitions

Plain-English explanations for acronyms and FDA terms used on this page.

U.S. Agent
Liaison for FDA communications and inspection scheduling for a foreign establishment (21 CFR § 807.3).
Official Correspondent
Administrative contact of record for FDA registration and device listing (included in Core and Plus).
FURLS
FDA Unified Registration and Listing Systems — the online portal for registration/listing administration.
Unique Device Identification (UDI)
System for uniquely identifying medical devices in the market; includes a Device Identifier (DI).
Device Identifier (DI)
The fixed, primary part of a UDI that identifies the labeler and specific device version/model.
GUDID
Global UDI Database where UDI data (including DIs) are submitted to FDA.
eMDR
Electronic Medical Device Reporting, filed via FDA’s ESG with an Account Owner (AO).
Service Level Agreement (SLA)
Our response commitments — e.g., FDA-labeled notices forwarded within 1 business day.