Last updated: [Insert date before launch]

Terms of Service

These Terms of Service (“Terms”) govern your access to and use of the AIFDA Intel platform operated by Lumenthis Labs LLC (“we”, “us”, “the Company”). By creating an account or using the platform, you agree to these Terms.

1. Acceptance of terms

By accessing or using AIFDA Intel, you confirm that you are at least 18 years old, have the authority to enter into these Terms (if acting on behalf of an organization), and agree to be bound by these Terms and our Privacy Policy.

2. The service

AIFDA Intel is a research and intelligence platform that aggregates, organizes, and presents publicly available records published by the U.S. Food and Drug Administration, including 510(k) clearance records, De Novo decisions, guidance documents, warning letters, and adverse event reports.

AIFDA Intel is an independent commercial platform. It is not affiliated with, endorsed by, or connected to the U.S. Food and Drug Administration or any other government agency.

3. Not regulatory or legal advice

Nothing on AIFDA Intel constitutes regulatory advice, legal counsel, or a prediction of FDA clearance outcomes. The platform organizes and presents public records for research purposes only. You are responsible for independently verifying all information before making regulatory, legal, or business decisions. For regulatory strategy or legal questions, consult a qualified regulatory affairs professional or licensed attorney.

4. Accounts

You are responsible for maintaining the security of your account credentials and for all activity under your account. Notify us immediately at hello@aifdaintel.com if you suspect unauthorized access. We reserve the right to suspend or terminate accounts that violate these Terms.

5. Subscriptions and billing

AIFDA Intel is a subscription service billed monthly or annually. Subscription fees are charged at the start of each billing period. All plans include a 14-day free trial — you will not be charged until the trial ends. You may cancel at any time from your account settings; access continues until the end of the current billing period. We do not offer refunds for partial periods except where required by applicable law.

We reserve the right to change subscription pricing with 30 days’ notice to existing subscribers.

6. Acceptable use

You agree not to: (a) use the platform for any unlawful purpose; (b) attempt to scrape, bulk-download, or systematically copy the platform’s content outside of features expressly provided; (c) share account credentials with users outside your permitted seat count; (d) resell or redistribute platform data as a standalone product; (e) attempt to reverse-engineer, decompile, or disassemble any part of the platform; or (f) interfere with the platform’s infrastructure or security.

7. Intellectual property

The underlying FDA data presented on AIFDA Intel is public domain. Our structured database, tagging system, predicate graph, summaries, UI, and associated software are proprietary to Lumenthis Labs LLC and may not be copied, modified, or distributed without our written permission. You retain ownership of any custom data you upload or configure within the platform.

8. Data accuracy

We sync our database daily from FDA’s public sources and make reasonable efforts to ensure accuracy. However, FDA’s own publication timelines mean some records may not appear immediately after FDA action. We make no warranty that the data is complete, current, or error-free. Always verify regulatory status directly at FDA.gov for time-sensitive or consequential decisions.

9. Limitation of liability

To the maximum extent permitted by applicable law, Lumenthis Labs LLC shall not be liable for any indirect, incidental, special, consequential, or punitive damages arising from your use of the platform, including but not limited to reliance on any data presented. Our total liability to you shall not exceed the amounts paid by you to us in the 12 months preceding the claim.

THE PLATFORM IS PROVIDED “AS IS” WITHOUT WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR NON-INFRINGEMENT.

10. Termination

We may suspend or terminate your access immediately if you breach these Terms. You may terminate your account at any time from account settings. Upon termination, your right to use the platform ceases immediately. Provisions that by their nature should survive termination — including Sections 3, 7, 9, and 11 — will survive.

11. Governing law

These Terms are governed by the laws of [State — insert before launch]. Any disputes arising from these Terms shall be resolved in the courts of [Jurisdiction — insert before launch]. If you are a consumer in the EU or UK, mandatory local consumer protection laws apply in addition to these Terms.

12. Contact

Lumenthis Labs LLC
hello@aifdaintel.com
[Physical address — add before launch]