If FDA registration testing fails, here are the general steps you should consider:

1. Understand the Failure Reason: Review the FDA's feedback or the test results carefully to identify the specific reasons for the failure. This could involve issues related to product safety, performance, labeling, or manufacturing processes.

2. Correct the Issues: Address the specific issues mentioned in the FDA's feedback. This might require redesigning the product, improving manufacturing processes, adjusting labeling, or conducting additional testing.

3. Consult with Experts: Consider consulting with regulatory experts or a third-party testing facility to help you understand the requirements more clearly and guide you through the process of addressing the failure.

4. Re-Test the Product: Once the necessary corrections are made, re-test the product, either in-house or through an FDA-approved third-party laboratory, to ensure compliance with FDA standards.

5. Submit Additional Documentation: If required, submit additional documentation, test results, or changes to the FDA as part of your new submission or resubmission.

6. Consider Resubmitting for FDA Review: After addressing the issues, you may need to resubmit your product for FDA review, depending on the nature of the failure and the changes you’ve made.

7. Stay in Communication with the FDA: Keep open communication with the FDA, as they may provide guidance on how to proceed with the next steps or clarification on requirements.

8. Appeal the Decision (if applicable): If you believe the FDA's decision is not justified, you may have the option to appeal the decision, though this can be a lengthy process.

Being proactive in addressing the issues and ensuring compliance will increase the chances of a successful FDA registration on the resubmission.

Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn