So, you’ve gotten FDA clearance – congratulations! Now what?
Have you completed a gap analysis on whether you are in compliance with FDA regulations? Before or after you received FDA clearance?
Typically gap anlaysis is more valuable pre-FDA submission. The reason is that depending on the gaps, fixing them can be done parallel to the FDA submission which takes an average of 6 months. This way, when you’ve received FDA clearance, your gaps are fixed and you are in a positive position to get your product to market – especially if the FDA came back and audited you.