Reporting Requirements for Studies Involving Investigational Devices

Version Date: April 29, 2010

University of Wisconsin-Madison Health Sciences Institutional Review Boards Adverse Events Reporting Guidelines for Studies Involving Investigational Devices

FDA Regulations require the investigator on a device trial to report to the IRB (and the sponsor) any unanticipated adverse device effect occurring during an investigation of the device. [21 CFR 812.150(a)]. An “unanticipated adverse device effect” is defined as either:

  1. Any serious adverse effect on health or safety or any life-threatening problem or death, caused by or associated with the device, if that effect, problem or death was not previously identified in nature, severity or degree of incidence in the investigational plan or application (including a supplementary plan or application); OR
  2. Any other unanticipated serious problem associated with the device that relates to the rights, safety or welfare of subjects. [21 CFR 812.3(s)].
The University of Wisconsin-Madison has adopted the following guidelines for reporting adverse events that occur on studies involving investigational devices:
Relevant Regulations Governing Adverse Event Reporting
45 CFR 46.103 (HHS) assuring compliance
21 CFR 56.108 (FDA) IRB functions and operations
21 CFR 312.32 (FDA) reporting requirement for sponsors
21 CFR 312.66 (FDA) reporting requirements for drug trials
21 CFR 812:150 (a) (FDA) reporting requirements for device trials - investigator
21 CFR 812.150 (b) (FDA) reporting rules for sponsors in device trials – sponsor
21 CFR 812.3 (FDA) Investigational Device Exemptions - definitions
21 CFR 812.46 (FDA) Investigational Device Exemptions – monitoring investigations