Reporting to the IRB: Unanticipated Device Effects in Medical Device Studies

As those familiar with medical device research are likely aware, there is some variation in the way medical device studies are regulated as compared to the regulations governing drug studies. When it comes to reporting to the institutional review board (IRB), however, the regulations are fairly similar.

According to the Food and Drug Administration’s (FDA’s) 2009 guidance document on adverse event reporting to IRBs, investigational device exemption (IDE) regulations “require sponsors to submit reports to IRBs in a manner consistent with the recommendations made…for the reporting of unanticipated problems under the IND regulations.”

However, unlike investigational new drug (IND) regulations, IDE regulations contain a unique term: unanticipated adverse device effect, or UADE.

Defining a UADE

A UADE is “any serious adverse effect on health or safety or any life-threatening problem or death caused by, or associated with, a 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 any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects” (21 CFR 812.3[s]).

Reporting UADEs should occur as follows:

• Investigators are required to submit a report of a UADE to the sponsor and the reviewing IRB as soon as possible, but in no event later than 10 working days after the investigator first learns of the event (21 CFR 812.150[a][1])
• Sponsors must immediately conduct an evaluation of a UADE and must report the results of the evaluation to FDA, all reviewing IRBs, and participating investigators within 10 working days after the sponsor first receives notice of the effect (21 CFR 812.46[b], 21 CFR 812.150[b][1])

At Advarra, when a serious adverse event (SAEs) or safety report does not meet the UADE criteria and is submitted to the IRB, the submitting party will receive acknowledgement of receipt only. The IRB will not review the item. When these items are submitted by a sponsor or contract research organization (CRO), Advarra’s default process is to generate an acknowledgement of receipt to all open sites, though sponsors/CROs may opt out of this process.

Note: This article was originally published October 2, 2019, and has been updated to include new and clarifying information.

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