> ## Documentation Index
> Fetch the complete documentation index at: https://glossary.micahealth.com/llms.txt
> Use this file to discover all available pages before exploring further.

# FDAAA 801 Violations

A system for documenting FDA violations of research reporting requirements, triggered when the FDA issues a Notice of Noncompliance to study researchers. The notice indicates failure to meet legal requirements under the Food and Drug Administration Amendments Act of 2007 (FDAAA 801), and includes three categories:

* Violations: Marked when the FDA issues and posts a Notice of Noncompliance for:
  ◦ Failing to submit required study information
  ◦ Submitting false or misleading information
  ◦ Omitting primary and secondary outcomes
* Corrections: Documented when researchers fix the violation and the FDA confirms and posts the correction, though there may be a delay between the update and the correction being noted
* Penalties: Recorded when the FDA imposes and posts consequences for the violation

The National Library of Medicine must add this information to study records when provided by the FDA.

## Related terms

<CardGroup cols={3}>
  <Card title="Eligibility criteria" href="eligibility_criteria" />
</CardGroup>

[*Source*](https://clinicaltrials.gov/study-basics/glossary)