FDA regulates medical devices and categorizes them into one of three classes (I, II or III) based on their level of risk. Class I and II devices are generally considered to be lower risk and require FDA clearance of an application referred to as a premarket notification (or 510(k)) in order for the device to be permitted to be sold in the United States. Class III devices, which tend to be higher risk and first-of-a-kind devices, require FDA approval in the form of a premarket approval (PMA) application.
When FDA’s medical device regulation program began in the late 1970s, FDA regulated over 100 Class III device types through the 510(k) program. The intent was that FDA’s regulation would be temporary and that over time, FDA would decide to reclassify those device types (or regulations) into Class I or II, or to sustain the classification in Class III and call for PMA applications.
The process of reclassification is described in FDA’s regulations in Section 515 of the Federal Food, Drug and Cosmetic Act. Over the years, FDA has made progress in this original list; however, as of 2009, 26 medical device regulations remained in this transitional state awaiting final classification. An example of one of the 26 device types is pacemaker programmers, classified under 21 CFR 870.3700, and with product code KRG.
Accordingly, in late 2009, FDA kicked off the 515 Program Initiative to facilitate the final adjudication of these remaining Class III device types.