There is no set number, and it depends on the risk of the IVD. You must tell your story and address the data you generate pre-market and the data you generate post-market. This includes items such as complaints, vigilance, and post-market performance follow-up activities.
GLOBAL BOTTOM CTA INSTRUCTIONS:
To display custom copy instead of global copy in this section, please go to Show Global Content for Bottom CTA? toggle in the "Contents" tab to the left, toggle it off, save, and then REFRESH the page editor, the custom text will then show up and ready to be edited.
Turning the global content back on will be the same process, go to the toggle and toggle it back on, save and refresh!