SOCRA CCRP Practice Exam

What is the definition of a UADE?

1. A standard malfunction of a device

2. A predictable adverse effect known before the device was marketed

3. Any serious adverse effect on health/safety, or any life-threatening problem or death associated with a device (if the effect was not already identified in a pre-market application)

4. A minor inconvenience caused by a device failure

The correct answer is: Any serious adverse effect on health/safety, or any life-threatening problem or death associated with a device (if the effect was not already identified in a pre-market application)

A UADE is a term used in medical device regulation, specifically in regards to adverse events. UADE stands for Unanticipated Adverse Device Effect and is defined as any serious adverse effect on health/safety or any life-threatening problem or death associated with a device. This definition includes any effects that were not already identified in the pre-market application, meaning the potential risks were not previously known. Option A is incorrect because UADEs are not a standard malfunction of a device. They are defined as unexpected and serious adverse effects, not just any malfunction. Option B is incorrect because UADEs are not predictable or known before a device is marketed. As mentioned in the definition, UADEs are unexpected and not identified in the pre-market application. Option D is incorrect because UADEs are not minor inconveniences caused by a device failure. They are defined as serious health/safety concerns