Terms of Service

Last updated: January 2, 2025

Who We Are

SMEDTEC OÜ ("we," "us," "our") is a regulatory intelligence research company registered in Estonia with registration number 17155971, located at Harju maakond, Tallinn, Kesklinna linnaosa, Ahtri tn 12, 15551, Estonia.

CFR Decoded by LENS ("the Service") is a web-based tool for navigating and understanding FDA medical device regulations (21 CFR Subchapter H).

Acceptance of Terms

By accessing or using CFR Decoded, you ("you," "your," "user") agree to be bound by these Terms of Service. If you do not agree with any part of these terms, you must not use the Service.

These terms apply to all users, whether you have a free or paid account, and whether you are an individual, company, or other organization.

What CFR Decoded Is (and Isn't)

What It Is

CFR Decoded is a research and navigation tool that:

• Provides searchable access to FDA medical device regulations (21 CFR Subchapter H)
• Generates AI-powered plain-English summaries of complex regulatory text
• Helps you organize research with bookmarks and notes
• Links regulations to FDA product codes and device classifications
• Supports regulatory professionals, manufacturers, researchers, and students

What It Is NOT

CFR Decoded is not:

• Legal advice: We are not lawyers. This tool does not provide legal, regulatory, or compliance advice.
• An official government resource: We are not affiliated with the FDA, U.S. Government, or GPO.
• A substitute for official CFR sources: Always verify compliance against the official Code of Federal Regulations.
• Guaranteed to be error-free: While we strive for accuracy, AI summaries and search results may contain errors or omissions.

Important Disclaimer

User Responsibilities

By using CFR Decoded, you agree to:

• Verify all information: Always cross-reference findings with official CFR sources before making compliance decisions
• Use responsibly: Do not use the Service for illegal purposes or to violate any regulations
• Respect intellectual property: Do not scrape, copy, or redistribute large portions of the Service's content
• Provide accurate information: Ensure your account details are accurate and up-to-date
• Keep your account secure: You are responsible for maintaining the confidentiality of your account credentials
• Use AI summaries appropriately: AI-generated summaries are interpretive aids, not authoritative legal text

AI Summary Fair Use

AI summaries are generated using OpenAI's language models and are subject to credit limits. By using AI summaries, you acknowledge that:

• Summaries are generated by AI and may contain errors, omissions, or misinterpretations
• Summaries are cached and may be shown to other users to improve performance and reduce costs
• You will not rely solely on AI summaries for compliance decisions
• Credit usage is tracked and may be subject to fair use limits to prevent abuse

Acceptable Use Policy

You may not use CFR Decoded to:

• Violate any laws or regulations
• Infringe on intellectual property rights
• Transmit harmful code (viruses, malware, etc.)
• Attempt to gain unauthorized access to our systems
• Scrape or harvest data using automated tools without permission
• Impersonate another person or entity
• Abuse AI summary credits through automated requests or sharing accounts
• Interfere with other users' access to the Service

Violation of this policy may result in immediate termination of your account without refund.

Intellectual Property

CFR regulations are public domain works of the U.S. Government and are not subject to copyright.

CFR Decoded's original content (including but not limited to: software code, user interface design, search algorithms, AI prompts, product code mappings, and branding) is owned by SMEDTEC OÜ and protected by copyright and other intellectual property laws.

Your content (notes, bookmarks, feedback) remains yours. By submitting feedback, you grant us a non-exclusive license to use it to improve the Service.

Account Termination

By You

You may close your account at any time by emailing [email protected]. Upon account closure, your personal data will be deleted in accordance with our Privacy Policy.

By Us

We reserve the right to suspend or terminate your access to CFR Decoded immediately, without prior notice, for any reason, including but not limited to:

• Violation of these Terms of Service
• Fraudulent or abusive behavior
• Non-payment (for paid accounts)
• Legal or regulatory requirements

Upon termination, your right to use the Service ceases immediately. We are not liable for any losses resulting from account termination.

Limitation of Liability

To the maximum extent permitted by law, SMEDTEC OÜ and its affiliates, officers, employees, and partners shall not be liable for any indirect, incidental, special, consequential, or punitive damages, including but not limited to:

• Loss of profits, revenue, or business opportunities
• Regulatory non-compliance or penalties
• Product recalls or safety issues
• Data loss or corruption
• Service interruptions or errors

Our total liability for any claims arising from your use of CFR Decoded shall not exceed the amount you paid us in the 12 months preceding the claim (or €100 if you have not paid us anything).

Service Availability

We strive to keep CFR Decoded available 24/7, but we do not guarantee uninterrupted access. The Service may be temporarily unavailable due to:

• Scheduled maintenance
• Technical issues or server outages
• Third-party service disruptions (e.g., OpenAI API downtime)
• Force majeure events

We are not liable for any losses resulting from service unavailability.

Changes to the Service

We reserve the right to modify, suspend, or discontinue any part of CFR Decoded at any time, with or without notice. We may also change pricing, features, or credit limits. Material changes will be communicated to registered users via email when possible.

Third-Party Links and Services

CFR Decoded may contain links to third-party websites or services (e.g., official CFR sources, FDA databases). We have no control over and assume no responsibility for the content, privacy policies, or practices of any third-party sites. You access third-party links at your own risk.

Governing Law and Disputes

These Terms of Service are governed by the laws of Estonia, excluding its conflicts of law principles.

Any disputes arising from these terms or your use of CFR Decoded shall be resolved through good-faith negotiation. If negotiation fails, disputes shall be subject to the exclusive jurisdiction of the courts of Estonia.

Changes to These Terms

We may update these Terms of Service from time to time. Material changes will be communicated via email to registered users at least 30 days before taking effect. What constitutes a "material change" is at our sole discretion.

Continued use of CFR Decoded after changes become effective constitutes your acceptance of the updated terms. If you do not agree to the new terms, you must stop using the Service.

The current version of these terms is always available at this URL, with the "Last updated" date at the top.

Severability

If any provision of these Terms is found to be unenforceable or invalid, that provision will be limited or eliminated to the minimum extent necessary, and the remaining provisions will remain in full force and effect.

Entire Agreement

These Terms of Service, together with our Privacy Policy, constitute the entire agreement between you and SMEDTEC OÜ regarding CFR Decoded and supersede any prior agreements.

Contact Us

If you have questions about these Terms of Service, please contact us:

• Email: [email protected]
• Subject line: "Terms Inquiry - CFR Decoded"

We will respond to all inquiries within 7 business days.