Terms of Service

1. Acceptance of Terms

By accessing or using KlearPath (klearpath.io), you agree to be bound by these Terms of Service. If you do not agree to these terms, do not use the platform. We may update these terms from time to time; continued use of the service after changes constitutes acceptance of the updated terms.

2. Description of Service

KlearPath provides AI-assisted tools to help medical device companies organize information and draft documents for FDA 510(k) premarket notification submissions. The platform generates draft documents, tracks submission readiness, and provides structured guidance based on the information you provide.

KlearPath is a drafting and organizational aid only. It is not a regulatory consulting service, legal service, or medical advisory service. AI-generated output should not be submitted to the FDA without independent review and verification by a qualified regulatory professional.

3. User Responsibilities

• You are solely responsible for reviewing all AI-generated content before use, submission, or distribution.
• You are responsible for ensuring that information you enter into the platform is accurate and complete.
• You must not use the platform to submit false, misleading, or fraudulent information to any regulatory authority.
• You are responsible for maintaining the confidentiality of your account credentials.

4. No Regulatory Advice

Nothing on KlearPath, including AI-generated documents, templates, guidance text, or any other content, constitutes regulatory advice, legal advice, or medical advice.

FDA submission requirements vary based on device classification, intended use, predicate selection, and many other factors specific to your situation. You should always consult with a qualified regulatory affairs professional before submitting any materials to the FDA. KlearPath is not responsible for regulatory outcomes arising from your use of the platform.

5. Intellectual Property

You retain ownership of the content and device information you input into KlearPath. By using the platform, you grant KlearPath a limited license to process and store that content solely to provide the service.

KlearPath owns all rights to the platform, its software, design, trademarks, and any proprietary content. You may not copy, reproduce, or redistribute any part of the platform without express written permission.

6. Limitation of Liability

To the fullest extent permitted by law, KlearPath and its operators shall not be liable for any direct, indirect, incidental, consequential, or punitive damages arising from your use of the platform, including but not limited to:

• Outcomes of any FDA regulatory submission.
• Reliance on AI-generated content without independent professional review.
• Data loss or service interruption.

Your use of the platform is at your own risk.

7. Termination

We reserve the right to suspend or terminate accounts that violate these Terms of Service, engage in fraudulent activity, or use the platform in a manner that could harm other users or third parties. You may also delete your account at any time by contacting us.

8. Changes to Terms

We may revise these Terms of Service at any time. We will indicate the date of the most recent update at the top of this page. Your continued use of KlearPath after any changes constitutes your acceptance of the revised terms.

9. Contact Us

If you have any questions about these Terms of Service, please contact us at contact@klearpath.io.