Draft Guidance for Industry and FDA Staff Medical Devices: The Pre-Submission Program and Meetings with FDA Staff

This FDA guidance document published on July 13, 2012 is being distributed for comment purposes only and contains nonbinding recommendations.

The following excerpt from the guidance document applies specifically to the issue of predicate selection:

2. Content of a Pre-Sub for a 510(k)

The Pre-Sub should contain sufficient information for FDA to provide advice to your specific questions. In addition to the information suggested in Section III of this guidance, we suggest that you also provide the following.

Proposed Predicate Devices

The 510(k) review process focuses on the comparison of a proposed device with a predicate device in terms of indications for use, technological characteristics, and, as appropriate, performance testing. As a result, you should provide a summary of the predicate device(s) you plan to use for your comparison of these characteristics, along with the indication(s) for use and technology of the device you would like to market (i.e., draft of your labeling).

For each predicate device you identify, we suggest you provide:

• the predicate device trade name, including model, if available;
• the 510(k) number under which the predicate device was cleared;
• the classification of the predicate device;38 and
• a comparison with the proposed device in terms of indications for use, technological characteristics, and performance testing.