Assurentry vs DIY FDA Registration
Save 20+ hours, prevent costly FURLS errors, and get 24 free compliance tools with ongoing monitoring -- starting at $199
Side-by-Side Comparison
12 features compared. See the time, risk, and effort you save with a professional compliance platform.
| Feature | Assurentry | DIY Registration |
|---|---|---|
| Setup Time | Complete onboarding in minutes | 8-24 hours learning FURLS, regulations, and requirements |
| Error Prevention | Expert-validated submissions with built-in compliance checks | High risk of errors in product codes, SIC codes, form fields |
| Ongoing Monitoring | Proactive alerts for regulatory changes and deadlines | No monitoring; must manually track every change |
| Renewal Management | Automated reminders + one-click renewal | Must remember; missed renewals risk product detention |
| U.S. Agent (Foreign) | Included at $399/yr for foreign facilities | Must find, vet, and contract an agent independently |
| Expert Support | Guaranteed <24hr response from compliance experts, 7 days/week | FDA help desk only; long wait times |
| Compliance Tools | 24 free tools (product code lookup, labeling reviewer, etc.) | No tools; must research manually on FDA.gov |
| Document Management | Secure cloud storage with version tracking | Must organize and store documents yourself |
| Acceptance Letters | Same-day delivery guaranteed | N/A -- no acceptance letter for self-registration |
| Real-Time Dashboard | Track all registrations and compliance status | Must check FDA.gov manually for status |
| Cost of Service | Starting at $199 (food facility) | $0 filing fee (but 8-24 hours of your time) |
| Multi-Facility Management | Manage all facilities from one dashboard | Must manage each registration separately in FURLS |
The True Cost of “Free” Registration
FDA registration filing is free. But the time, risk, and ongoing burden make DIY far more expensive than it appears.
Your Time
8-24 hours of research and form completion
Minutes to onboard; we handle the rest
Wrong Product Codes
Common error that triggers FDA scrutiny
Expert-validated before submission
Missed Renewals
Must remember to renew biannually (food) or annually
Automated reminders + one-click renewal
No U.S. Agent
Must find and contract an agent separately (if foreign)
U.S. Agent included at $399/yr
Regulatory Changes
Must manually monitor Federal Register for changes
Proactive alerts for changes affecting you
Why Not DIY?
The hidden costs and risks of doing FDA registration yourself
Avoid Costly FURLS Mistakes
The FDA's FURLS system is notoriously complex. Incorrect product codes, wrong SIC codes, or improperly categorized products can trigger FDA scrutiny, import alerts, or registration rejection. Assurentry validates your data before submission to prevent these costly errors.
Never Miss a Renewal Deadline
FDA food facility registrations must be renewed biennially during October-December. Missing this window means your registration lapses and your products can be detained. Assurentry sends automated reminders and offers one-click renewal.
24 Free Compliance Tools
Product code lookup, ingredient checker, labeling reviewer, import alert monitor, compliance calculator, renewal tracker, warning letter search, and 17 more tools -- all included. Doing it yourself means researching each question manually on FDA.gov.
You Need a U.S. Agent (If Foreign)
FDA requires all foreign food, drug, device, and cosmetics facilities to designate a U.S. Agent. Finding a qualified agent on your own is time-consuming and risky. Assurentry provides U.S. Agent representation as part of the service.
Compliance Does Not End at Registration
Filing your FDA registration is just the beginning. You need to track regulatory updates, manage renewals, monitor import alerts, and maintain documentation. Assurentry provides ongoing compliance monitoring so you stay compliant.
The Real Cost of Free
While FDA registration filing is free, the time investment (8-24 hours), risk of errors, and ongoing monitoring burden make DIY registration far more expensive than it appears. A single FDA Warning Letter can cost your business far more than a $199 registration fee.
Don't risk your FDA registration
A single FURLS mistake can trigger an import alert or FDA Warning Letter. Let Assurentry handle it for you -- starting at $199 with 24 free tools included.
Start My RegistrationCommon Questions
Understanding the risks and trade-offs of DIY FDA registration versus using a professional platform.
Let the Experts Handle It
Save 20+ hours, prevent costly errors, and get 24 free compliance tools with ongoing monitoring. Start your FDA registration with Assurentry today -- starting at $199.