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In his module we are going to talk about the two main pathways for devices, the 510(k) and the PMA. Letamp;#39;s start with 510(k). Can you talk us through the basics of the clearance process? Sure, 510(k) is for devices that are substantially equivalent to other 510(k)amp;#39;d devices. FDA clears these products for marketing, but does not approve them. Approval is limited to a more detailed review of the product safety and effectiveness for PMA devices. In 1976, when the device law was enacted, FDA took everything that was on the market, and placed into one of three regulatory categories: Class I, Class II, or Class III.Class I and II products are those that are eligible for 510(k)s, Class III products were allowed to remain on the market until FDA called for PMAs. What this is done over time, of course, is to attenuate somewhat the comparisons since it is a little difficult to compare a 2009 device to something in the market before 1976. So, to avoid this situation where you are c
