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What’s the difference between FDA Approving (approved, approval) and Clearing (Cleared, Clearance) a medical device?

The two terms have very specific significance with the FDA.  The FDA does not “approve” 510(k)s – they clear them.  They do approve PMAs. 

When the FDA “Approves” something – they essentially stick their necks out on the product.  They are as much responsible as you the manufacturer.  That’s why a PMA costs so much and why the magnitude of the amount of work required (from a 510k) is considerably greater.