"Indication for Use" Identifying Specific Procedures


Inactive Registered Visitor
Greetings everyone,
I have come across 510k summary documents where the following phrase is used in Indication for Use. I include generic description of text before and after the statement to help understand the context:
<few lines describing intended use of the device>
The subject device supports, but is not limited to, the following surgical procedures:
<procedure 1>
<procedure 2>
<procedure 3>

My clarification:
Is there any advantage for using the phrase "but is not limited to" in the indication for use? Does this give the manufacturer of the subject device the ability to claim other procedures in their promo material provided the procedures are closely related to those listed in the indication for use?
I have seen such text in patents where the intent is to claim that other similar methods are already anticipated in the submission. I doubt such broad claims can be claimed in Indication for Use.
Or, am I reading too much into this and I should merely interpret said text as text that simply lists the indicated procedures?

Any and all pointers will be much appreciated.


Some FDA reviewers will balk at an open-ended indication like that, because it might be used to claim conformance at a later time for a procedure that the reviewer otherwise would have rejected.

In my experience, many FDA reviewers would rather that the application describe what is common about the entire class of procedures that are to be included in indications. Then there is an objective basis for managing the applicability of the PMN or PMA.

There always are examples to be found in FDA's work of deviations from norms, though.


Inactive Registered Visitor
I agree with your observation as well; however, this is a terminology that I observed in a cleared 510k summary. I thought I was missing a lingo that was perhaps commonplace in indication for use.
Last edited:
Top Bottom