Intended Use and Indications for Use

ND320 C2 L4 05 Intended Use And Indications For Use Walkthrough Pt 1

ND320 C2 L4 06 Intended Use And Indications For Use Walkthrough Pt 2

Typo in the video: it is '510k' not '501k'

ND320 C2 L4 07 Intended Use And Indications For Use Walkthrough Pt 3

Summary

Intended use

The FDA will require you to provide an intended use statement and an indication for use statement. The intended use statement tells the FDA exactly what your algorithm is used for. Not what it could be used for. And FDA will use this statement to define the risk and class of your algorithm.

Indication for use

You can use the indications for use statement to make more specific suggestions about how your algorithm could be used. Indications for use statement describes precise situations and reasons where and why you would use this device.