1. Informational Purpose Only
Drua provides general information about FDA medical device regulations, quality systems, and related regulatory frameworks. The information provided is for educational and informational purposes only and does not constitute legal, regulatory, or professional advice.
2. Not a Substitute for Professional Advice
The content generated by Drua should not be relied upon as a substitute for consultation with qualified regulatory affairs professionals, legal counsel, or other licensed experts. Always seek professional guidance for your specific regulatory situation.
3. No Guarantee of Accuracy
While Drua strives to provide accurate and up-to-date information, regulations and guidance documents change frequently. Drua makes no warranties or representations regarding the completeness, accuracy, or timeliness of any information provided. Users are responsible for verifying all information with official FDA sources and applicable regulations.
4. FDA Submission Disclaimer
Drua does not prepare, review, or submit regulatory documents to the FDA or any other regulatory body on your behalf. Any content generated is a starting point only and must be reviewed, validated, and finalized by qualified professionals before use in any official regulatory submission.
5. Limitation of Liability
Drua Consulting and its affiliates shall not be liable for any damages, losses, or regulatory consequences arising from the use of or reliance on information provided by this service. Use of this service is entirely at your own risk.
6. Confidentiality
Do not share confidential, proprietary, or sensitive business information through this platform. While we take reasonable measures to protect your data, we cannot guarantee the security of information transmitted through this service.
7. Acceptable Use
This service is intended for medical device professionals, startups, and organizations seeking regulatory guidance. Misuse of this service, including attempts to circumvent usage limits or use the service for unlawful purposes, is strictly prohibited.
8. Credits and Payment
New users receive 3 complimentary questions. Additional questions require the purchase of credits. All purchases are final and non-refundable unless required by applicable law.
9. Changes to Terms
Drua reserves the right to modify these Terms of Use at any time. Continued use of the service constitutes acceptance of any updated terms.
10. Governing Law
These Terms of Use shall be governed by and construed in accordance with the laws of the State of California, without regard to its conflict of law provisions.