Application of the Rules - Flow Diagram Part 3
"Other Uses" not for transmissible diseases
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).
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