FDA update – February 2, 2011

FDA’s 515 Initiative program

In the late 1970s, when FDA’s medical device regulation program began FDA regulated over 100 Class III device types through the 510(k) program.

This classification was temporary and so over the 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.

So, FDA has started 515 initiative programs to facilitate the final adjudication of remaining Class III device types.

There are 5 basic steps in 515 Process, which are as follows:

Step 1 - FDA collects existing information

  • Publish Federal Register Notice to solicit information
  •  Hold FDA advisory panel meeting (optional)

Step 2 - FDA assesses the risks and benefits

  • Assess the risks versus benefits, as well as the clarity of knowledge of the medical device type subject to the reclassification

Step 3 - FDA proposes classification into Class I, II, or III

  • Announced as a proposed rule in Federal Register Notice 
    If Class II, then may publish draft guidance describing the special Controls or may include special control directly in regulation
  • Issue a proposed rule (proposed classification) of the device type into Class I, II, or III;

Step 4 - FDA receives and reviews comments provide


Step 5 - FDA finalizes classification into Class I, II, or III

  • Announced as a final rule in Federal Register Notice
  • If Class II, then may publish final special controls guidance document

It should be noted that while the fifth step is considered to be the final decision of the 515 Program Initiative, the device categorization is not necessarily permanent.

In the future, as with any other device type, FDA may subsequently choose to change the classification of a medical device type area to any other class.

Any questions on the 515 initiative please email us at info@mdiconsultants.com and ref: 515.