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 life-threatening diseases or conditions are
involved. False negative results can lead to a delay in establishing the correct
diagnosis, failure to start or continue needed treatment, false security that may
prevent timely follow-up and retesting, and contribute to the potential spread of
infectious agents to others. If the potential risk does not rise to the level described
above, the study is not considered to pose a significant risk. FDA recommends the
sponsor consider all these factors when determining the risk associated with your
investigational IVD.
