News & Insights


We Just Had an Adverse Event Caused by a Medical Device! What Next?

On Monday, August 4, 2014, we will be hosting a Roundtable focused on the challenges that hospital systems and other providers face in complying with FDA requirements for identification, analysis and reporting of certain adverse events associated with medical devices. We will also discuss the appropriate use of the legal framework of Patient Safety Organizations (PSO) for conducting the analysis of potential safety events involving medical devices.

In this Roundtable, a panel of King & Spalding experts from our Healthcare and FDA Life Sciences practices will discuss the applicable law and regulations, walk through potential pitfalls and discuss actionable strategies. The panel will also emphasize proactive steps that can be considered to navigate and mitigate risks in the analysis of potential patient safety events.

The Roundtable will include the following topics:

  • Understanding FDA's User Facility Reporting Requirements under 21 C.F.R. 803, including how to analyze whether a medical device may have caused or contributed to a serious injury;

  • Appreciating the relationship of event analysis under a Patient Safety Organization and the FDA reporting obligation;

  • Practical "take home" recommendations that healthcare providers can consider to mitigate risk.

General information on our practice is available in our electronic publications Serving the Healthcare Industry, Around the Corner and Serving the Life Sciences Industry. If you would like to be included on our regular pharmaceutical manufacturers, medical device manufacturers or healthcare provider mailing lists to receive notices of other events and written updates, you can be added by submitting your full contact information to and specifying the list you wish to join.

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If you have questions concerning this Roundtable, contact Marie Parks at

Event Details

Date: August 4, 2014

Time: 8:00 pm