An Alternative to Your Current FDA Registration Provider
Trusted by 1,000+ companies across 135+ countries, with 15+ years of FDA regulatory experience. Below: what you actually own, the signs it's time to look, what to evaluate, and how a clean switch works.
You Own Your Registration — Not Your Provider
This is the part many companies don't realize: your FDA registration is tied to your facility and its identifiers — the registration number, the PIN, and the DUNS Number. A provider acts as your U.S. Agent and filer, but the registration itself is yours to keep and to move.
That means you're never locked in. You can change who manages your registration, or who serves as your U.S. Agent, without cancelling anything and without an FDA penalty — your registration number stays the same.
Signs It Might Be Time to Switch
None of these is unique to any one provider — they're simply the issues companies most often cite when they start looking. They're worth checking against your current arrangement:
What to Look For in a Provider
| Look for | Why it matters |
|---|---|
| A responsive U.S. Agent | FDA communications route through the agent and can be treated as reaching you |
| Transparent, predictable pricing | Avoids surprise renewal or per-request fees |
| Active renewal management | Food/cosmetic biennial, drug/device annual — a missed renewal stops imports |
| Coverage across your categories | One firm for food, drug, device, and cosmetic if you span them |
| Direct access to your records | You should always be able to get your registration number, PIN, and DUNS |
How Switching Works
What We Cover
Registration & U.S. Agent
Food, drug, medical device, and cosmetic (MoCRA) facility registration and listing, with U.S. Agent service in one place.
Filings & Renewals
FSVP, Prior Notice, FCE/SID, and labeling review, plus renewal tracking on the correct biennial or annual schedule.
Switch Without a Gap in Coverage
Send us your registration number, DUNS, the product categories you sell, and your renewal timing. We'll confirm what's needed, update the U.S. Agent and account details without a lapse, and keep your registrations and renewals on track from there. Email info@fdaregistrationassistance.com or call +1 (928) 275-8333.
Frequently Asked Questions — Switching FDA Providers
Can I switch my FDA registration provider?
Yes, at any time. Your FDA registration belongs to your facility, not to your provider, and the FDA does not penalize you for changing your U.S. Agent or the firm that manages your registration.
Do I own my FDA registration?
Yes. The registration is tied to your facility and its identifiers — the registration number, PIN, and DUNS Number. A provider acts as your U.S. Agent or filer, but the registration itself is yours.
Will switching cause a gap in my registration?
It shouldn't. A proper switch keeps your registration active throughout — you update the U.S. Agent designation and account details without cancelling the registration, so there is no lapse.
Why do companies change FDA providers?
Common reasons include an unresponsive U.S. Agent, surprise or rising fees, missed or lapsed renewals, difficulty getting their own registration details, filings that weren't actually completed, or needing one firm across several product categories.
Why does an unresponsive U.S. Agent matter so much?
Because the FDA routes communications through your U.S. Agent, and for many purposes that contact is treated as reaching you — see why the U.S. Agent role matters. An unresponsive agent can mean missed questions and delays.
What information do I need to switch?
Your facility's FDA registration number, PIN, and DUNS Number, plus any account credentials. A good provider hands these over readily; difficulty getting them is itself a reason to switch.
What if my current provider won't give me my details?
Your registration information belongs to your facility. If a provider makes it hard to access your own registration number, PIN, or DUNS, that's a red flag — and there are still paths to recover access and move forward.
How long does switching take?
Updating a U.S. Agent designation and account details is usually quick once you have your registration information. The key is sequencing it so the registration never lapses during the change.
Does the FDA charge to change my U.S. Agent?
No. The FDA doesn't charge to update your U.S. Agent or registration details. Any cost is the new provider's service fee, not an FDA fee.
Is there a good time to switch?
Switching well before a renewal deadline is ideal, so the new provider can manage the renewal cleanly. That said, you can switch at any point in the registration cycle.
Can I switch in the middle of my registration period?
Yes. You don't have to wait for renewal. The U.S. Agent and account details can be updated at any time during the period without disturbing the registration itself.
What should I look for in an FDA provider?
Responsiveness, transparent and predictable pricing, active renewal management, coverage across the product categories you sell, U.S.-based accessibility, and easy access to your own registration records.
What if I have food, drug, and device products?
Look for a provider that covers all the categories you sell. Spreading food, drug, device, and cosmetic registrations across several firms makes renewals and communications harder to track and easier to drop.
Do device U.S. Agent changes have special rules?
Yes. For medical devices, a change in the U.S. Agent must be reported to the FDA within 10 business days and confirmed in its system, so the switch should be handled carefully.
Will my registration number change when I switch?
No. Your facility keeps the same registration number. Switching the provider or U.S. Agent doesn't create a new registration; it updates who manages and is listed on the existing one.
Can you act as my U.S. Agent?
Yes. We serve as the U.S. Agent for foreign facilities across food, drug, device, and cosmetic registrations, and manage the associated filings and renewals under one engagement.
What happens to my renewals when I switch?
A good provider takes over tracking your renewal schedule — biennial for food and cosmetic facilities, annual for drug and device establishments — so nothing lapses during or after the switch.
Is switching providers risky?
The bigger risk is usually staying with a provider that's unresponsive or letting renewals slip. A well-sequenced switch keeps the registration active and often reduces compliance risk rather than adding it.
Will I lose my compliance history?
No. Your registration, listings, and history stay with your facility. You're changing who manages them, not erasing them, and the underlying records remain intact.
Do I need to tell the FDA I'm switching?
You don't file a “switch” notice as such; you update the U.S. Agent and account details in the FDA's system. For devices, the agent change carries the 10-business-day reporting rule.
Can you review whether my current registration is even correct?
Yes. Part of moving over is checking that your facility registration, U.S. Agent, listings, and any process or product filings are accurate and current. Switching is a good moment to catch and fix errors.
What if my renewal is overdue?
That's a common reason companies switch. We can help bring an overdue or lapsed registration back into good standing and then keep it current going forward on the correct schedule.
Do you handle FSVP and other filings too?
Yes. Beyond U.S. Agent service, we support FSVP, Prior Notice, FCE/SID, labeling, and listings, so your compliance can sit with one team instead of several.
How do I start the switch?
Send us your registration number, DUNS, the product categories you sell, and your renewal timing. We'll confirm what's needed and handle the U.S. Agent and account updates without a lapse.
How do I get in touch?
Email info@fdaregistrationassistance.com or call +1 (928) 275-8333 with your facility and registration details. You can also reach our team here, and we'll map a clean switch with no gap in coverage.
