Reporting To The IRB: Unanticipated Device Effects In Medical Device Studies

By Lauri Carlile EVP, Global Review Services

As individuals familiar with medical device research may know, there are distinct regulatory frameworks governing medical device studies compared to those for drug studies. However, when it comes to reporting requirements to the institutional review board (IRB), the regulations exhibit notable similarities.

The Food and Drug Administration (FDA)’s 2009 guidance on adverse event reporting to IRBs outlines that investigational device exemption (IDE) regulations mandate sponsors to submit reports to IRBs in a manner consistent with the guidelines for reporting unanticipated problems under investigational new drug (IND) regulations.

One significant difference between IDE and IND regulations lies in the terminology used. IDE regulations introduce the concept of unanticipated adverse device effect (UADE), which is specific to adverse events related to medical devices undergoing investigation. This term reflects the unique considerations and safety assessments required for medical devices during clinical trials, highlighting the distinct regulatory landscape within which device studies operate compared to pharmaceutical studies.