Question

What is the difference between “clearance” and “approval” of a product? Define the two pathways in which these two statuses are issued.

Answer 1

clearance of a product is for those products which are already in the market which has to be cleared by the FDA and prove to cause no harm before it is medically used

approval of products is for those products which are completely new and need to be inspected for safety from causing hazards

pathway of clearance of products:

• products are labelled as pre amendment products
• proved as substantially equivalent to products priorly in the market
• once proved, FDA clears the product for commercial distribution in the market

pathway of approval of products:

• products labelled as new concept medical product
• should undergo a process which is cumbersome and expensive for the manufacturer as there is no existing medical history of the product
• after it gets approval from the FDA ,it gets legal authorization to market to export the the new product