Application of the Rules - Flow Diagram Part 3

"Other Uses" not for transmissible diseases

Rule 4

An IVDD used for diagnosis or patient management is classified as Class II unless they are used for the following, then they are Class III:

• Screening/diagnosis of cancerGenetic testing;
• Screening congenital disorder in the fetus;
• If there is risk an erroneous diagnostic result would cause death or sever disability (cardiac markers, fetal, neonatal testing, and late-onset disorders).