FDA’s 515 Program Initiative

  • Date: January 27, 2011
  • Source: Admin
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FDA regulates medical devices and places them under one of the three classes, viz., Class I, Class II and Class III, based on the level of risk they carry.  Class I and Class II devices are generally regarded as low-risk devices.  They require FDA Clearance of an application called Premarket Notification ((or 510(k)) if the device is to be permitted to be sold in US.  Class III devices, which tend to be high-risk devices and first-of-a-kind devices, require FDA Approval in the form of a Premarket Approval (PMA) Application.  

When the medical device regulation program was introduced in the late 1970s, the FDA regulated 100 plus Class III device types through the 510(k) program.  It was felt that FDA’s regulation would be temporary and over time, the FDA would reclassify those device types into Class I or II, or 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; as of 2009, 26 medical device regulations remained in this transitional state awaiting final classification. In 2009, FDA kicked off the 515 Program Initiative to facilitate the final adjudication of these remaining Class III device types.

515 Process Steps

FDA takes the following five steps for each medical device type:

  • collect existing scientific information in the public domain and/or from scientific experts;
  • assess the risks versus benefits, and the clarity of knowledge of the medical device type subject to the reclassification;
  • issue a proposed rule of the device type into Class I, II, or III;
  • receive and review comments submitted by the public;
  • issue a final rule on the device type to Class I, II, or III.



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