29. HHS Guidance on PSOs and FDA Reporting

Director's Update

• 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.

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