U.S. Agent for Medical Devices & IVD

Appoint CENIT as your U.S. FDA Agent — Today - Select the right Plan for you

We serve foreign medical device & IVD establishments as your designated U.S. Agent (liaison-only under 21 CFR § 807): forwarding FDA-labeled notices fast and coordinating inspections. Pick the scope you need.

FDA-labeled notices → 1 business day
Foreign establishments only
Devices & IVD only — not for drugs/biologics/food
Get Lite — $329/yr Popular Compare plans
Prefer more help? Core — $725/yr • Plus — $1,350/yr

U.S. FDA Agent — what you get (and how we help)

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

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)

  • 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?

  • You are a non-U.S. device/IVD establishment (manufacturer, spec developer, reprocessor, etc.) selling into the U.S.
  • You require a designated U.S. Agent for FDA communications and inspection coordination.
  • Based in the U.S.? You typically do not need a U.S. Agent, but we can help with other services.
See pricing
Transparent scope, predictable SLAs, and fast onboarding.

Simple pricing, clear scope

Pick the level of involvement you need. Upgrade anytime.

Lite
$329 / yr
  • FDA Registered Address (Agent)
  • Forwarding of FDA notices
  • Email support
Get Lite — 329/yr
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Core Best value
$725 / yr
  • Everything in Lite
  • Official Correspondent (OC) setup
  • Priority response
Get Core — $725/yr
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What’s included in each plan

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

Essential U.S. Agent (Lite)

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
Agent Core Most popular

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 (admin scope)
  • 1 consulting hour/year
Not in Core
  • GUDID Regulatory Contact
  • eMDR Account-Owner setup
  • Large UDI projects
Agent Plus

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, or complex submissions
Need mass UDI or 510(k)/De Novo/PMA help? We offer this as a separate service — see services.
Feature
Lite
Core
Plus
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)
—
—
✓
Criteria
CENIT
Distributor as Agent
Generic agency
In-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.

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. Most switches complete within 1–2 U.S. business days once we have your details and FURLS access.

1 Checkout & agree

Subscribe to Lite / Core / Plus and accept terms (≈2 minutes). If you’re switching from another agent, your year-1 discount applies automatically.

2 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.

3 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.

4 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

  • 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 when moving from another agent.

Timeline assumes intake is completed and (if we’re not filing on your behalf) you provide FURLS access promptly during U.S. business hours. “48 hours” = two U.S. business days.

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 the client portal or 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.