These two words get used interchangeably outside the industry and they shouldn't be, because they represent entirely different regulatory pathways with different timelines, different evidence requirements, and different costs.
Clearance, through the 510(k) pathway, applies to a device that's substantially equivalent to something already legally on the market. The evidence bar is lower because you're demonstrating similarity to an existing, already cleared device, not proving safety and effectiveness from first principles. This is the pathway most incremental medical device innovation follows.
Written by John M. Abrahams, MD — board-certified neurosurgeon, founder of New York Brain & Spine Surgery.
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