Obtaining Regulatory Approval to Market - Medical Device Design: Innovation from Concept to Market - page 314

b. Use an example of good practice from another medical device manufacturer; you

only need ask and a refusal should not offend.

And another suggestion:

c. The FDA examiners are extremely helpful, so why not ask them?

14.4.1 Substantial Equivalence (SE)
Section 12 is very important. This is the section where you claim “substantial equivalence”:
your device is so similar to other devices in the market that it is - in effect - the same. This
simple section helps tremendously. But to do this you must find precedents. This is done
using the FDA 510(k) search engine (in a similar vein to that shown in previous chapters).

For example, let us suppose your company wishes to register a c-arm image intensifier. The
510(k) search results are shown in Figures 14.1 and 14.2 .

The results of your 510(k) search will help you with your submission. In Figure 14.2 , the
item circled #1 is the 510(k) number you must refer to in your SE discussion; #2 identifies the
relevant FDA codes (again, you must refer to these for any specific standards you have used); #3

Figure 14.1
510(k) search result for c-arm.