Guidance: Medical device stand-alone software including apps (including IVDMDs) v1.06
Concerning a congenital abnormality Software that gives information about an acquired or inherited condition or disease from results generated by an IVD. Results may be quantitative or qualitative and can be entered manually by the user or automatically from the IVD. Examples that may be devices include: • Apps and software that are intended for detecting and interpreting mutations in DNA • Apps and software that are intended for determining risk of trisomies
Indicative words and phrases:
DNA Genomics Data analysis Big Data Next Generation sequencing...
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Introduction
Device decision flow chart
Medical purpose flow chart
Medical devices
In vitro diagnostic medical devices
Active implantable medical devices
Non medical devices
Index
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