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March 28, 2024   

Reporting Medical Device Events for Physician Organizations

This Bulletin is brought to you by AHLA’s Physician Organizations Practice Group.
  • March 28, 2024
  • Jeremy L. Belanger , Studebaker Nault PLLC

Under the Safe Medical Devices Act and its implementing reporting regulations, a user facility (UF), which includes hospitals, ambulatory surgical facilities, nursing homes, outpatient diagnostic facilities, and outpatient treatment facilities (other than a physician’s office), are required to report a “serious injury” or death when the UF receives any information that “reasonably suggests” that a device has or may have caused or contributed to a serious injury or death (Reportable Events). The Food and Drug Administration (FDA) permits, but does not require, other health care providers to make voluntary reports. This article does not address the reporting obligations of manufacturers.


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