We have seen the gamut from lower risk to higher risk devices needing PMCF. For example, we had a pretty well-established Class IIa device that had limited clinical data that was not high quality. They used equivalence and then got a finding asking them to prove they had sufficient clinical evidence for initial conformity based on the studies they did have.
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!