Why do some medical devices & drugs have FDA approvals, whereas others only have FDA clearance? What is the difference?
The FDA only grants “Approvals” for drugs and medical devices that are either: 1) categorized as a Class III (which means they are life-threatening, life-sustaining, implanted or present unreasonable risk of injury or illness) or; 2) are new products that contain new materials or differ in design from that which is already on the market.
If there is a medical device that has already been approved by the FDA for the same intended use and similar in technical characteristics, then the FDA only grants “clearance” (pre-market approval) to market the new substantially equivalent medical device on the market. Capillus laser devices are classified as Class II medical device and were substantially equivalent to comb and helmet predecessors on the market and thus not a candidate for the FDA approval process.