29. HHS Guidance on PSOs and FDA Reporting
- The Guidance:
- Permits all mandatory reporting to the FDA [Food and Drug Administration] as required by Federal law or regulation.
- Allows FDA to inspect the facilities of PSOs [Patient Safety Organizations] with FDA mandatory reporting obligations.
- Permits FDA to use the information obtained from its inspections to carry out its enforcement responsibilities.
- States that a PSO that does not meet these obligations would be creating a conflict of interest and can be delisted by AHRQ.