Passing the Mark: The Three Different Levels of FDA Validation Errors

Understanding the differences between low, medium, and high validation errors in the FDA’s eCTD (electronic Common Technical Document) validation process is critical for successful submissions. Errors are categorized into three severity levels—low, medium, and high—each carrying different implications for the submission process. Read on for a breakdown of these error levels and what they mean for your eCTD submission.

1. Low Validation Errors

Low validation errors are typically minor technical issues that don't affect the overall reviewability of the submission. These are more like warnings rather than hard stops, and they can often be resolved without resubmitting the entire application. However, low validation errors can accumulate and impact the efficiency of FDA’s review process, which affects your reputation with the agency and could even impact whether or not an application is accepted or rejected when combined with other issues.

Examples of low validation errors include:

• Misnaming forms like the 1571 (e.g., not including “1571” in the filename)

• Minor discrepancies in metadata, such as STF title and leaf element title mismatch.

How to address them:

While these errors don’t prevent your submission from being reviewed, it’s still best practice to avoid them when possible and to put processes in place to avoid them in the future.

2. Medium Validation Errors

Medium validation errors are more serious than low errors because they can disrupt the review process and affect the FDA’s ability to easily navigate or understand parts of the submission. While medium errors don’t necessarily prevent the FDA from starting the review, they signal technical issues that could slow down the process, lead to queries from the agency, or require corrections and resubmission.

Examples of medium validation errors include:

• Bookmarks or links that are broken, do not inherit zoom, or links that aren’t relative

• Use of non-standard fonts that are not embedded, which can cause display issues.

How to address them:

Medium validation errors should be resolved before submission, or at least as quickly as possible once identified. The FDA may request corrections or clarifications before proceeding with its review, which could delay both acceptance and approval of your submission. If you do have to submit with medium-level errors in order to meet deadlines, it’s important to have a plan in place to correct the issues as quickly as possible if FDA requests it so that the review clock doesn’t stop and your milestones are met on time.

3. High Validation Errors

High validation errors are the most serious and can completely halt the review process. These errors make the submission non-compliant with eCTD specifications, and as a result, the FDA will typically reject the submission until the errors are corrected. High validation errors indicate critical technical problems that prevent the FDA from accessing or reviewing key components of the submission.

Examples of high validation errors include:

• Missing required files (e.g., module 1 forms or required datasets in modules 4 and 5).

• Incorrect submission type, sub-type or submission-id

How to address them:

High validation errors typically require immediate correction and resubmission. These errors are potential showstoppers, often leading to immediate technical rejection or with FDA choosing to not proceed with its review until the submission meets the necessary technical standards. Addressing these errors before submission is your best bet for avoiding any significant delays.

How to Minimize FDA Validation Errors

To reduce the risk of validation errors at any level, consider the following best practices:

• Adherence to Standards: Always adhere to FDA’s eCTD guidelines, including the formatting of files, metadata, and hyperlink/bookmark structures.

• Quality Control: Perform a thorough quality check on your submission to ensure that everything is properly formatted, readable, and accessible.

• Validation Tools: Use FDA-compliant eCTD validation tools to check your submission before submitting. These tools will flag any low, medium, or high errors so you can resolve them beforehand.

Conclusion

Low, medium, and high validation errors in the FDA’s eCTD submissions differ in severity and implications. While low errors might be more of an inconvenience, medium and high errors can disrupt or even halt the review process entirely. By understanding the nature of these errors and implementing best practices to avoid and/or resolve them, you can dodge delays and ensure a smooth submission process.

If you need help with submission readiness, quality control or eCTD application preparation, The Sugar Water Operations Team is here to help. With over twenty years of experience, our eCTD experts can ensure your deliverables are technically compliant and ready for FDA submission and review. Reach out today to chat about how we can help you meet your milestones.

Reference

FDA’s Specifications for eCTD Validation Criteria: https://www.fda.gov/media/87056/download