How do I determine if the study is a significant or non-significant risk study and how do I determine if an invasive sampling technique presents a significant risk under 21 CFR 812.2(c)(3)?
A significant risk IVD device is generally one that is for a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health and presents a potential for serious risk to the health, safety, or welfare of a subject or otherwise presents a potential for serious risk to health, safety, or welfare of a subject. 21 CFR 812.3(m). For IVDs, we interpret “potential for serious risk” in relation to the nature of the harm that may result to the subject. Misdiagnosis and/or error in treatment caused by inaccurate test results would be considered a significant risk if the potential harm to the subject could be life-threatening, or could result in permanent impairment of a body function or permanent damage to the body structure. False positive results can lead to unnecessary confirmatory testing, unnecessary treatment that can be invasive or have harmful side effects, and/or unnecessary psychological trauma when serious or lif
Related Questions
- How do I determine if the study is a significant or non-significant risk study and how do I determine if an invasive sampling technique presents a significant risk under 21 CFR 812.2(c)(3)?
- What is the difference between a significant risk (SR) device and a non-significant risk (NSR) device?
- Is my study significant risk or nonsignificant risk?
