29. HHS Guidance on PSOs and FDA Reporting

Director's Update

Text version of slide presentation from a National Advisory Council meeting.

Text Description is below the image.

  • 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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Page last reviewed August 2011
Internet Citation: 29. HHS Guidance on PSOs and FDA Reporting: Director's Update. August 2011. Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/news/events/nac/2011-04-nac/clancy/slide29.html