New 510k requirements for Change in Indications for Use

robert.beck

Quite Involved in Discussions
#1
Hi there,

first some background .. am familiar with the guidance doc on when to submit a new 510k, have read the 2010 510k working group report which discussses intended use vs. indication for use. here is my question:

the device has an approved 510k from 2007. at that time it was developed as an adjunct to another medical device which is now becoming obsolete. the company that makes this device makes many other similar models, and so do its competitors.

we've made a new version which works better and even considering all of the changes for this new version, a new 510k is not needed. so from a technology, risk, materials, patient population, warnings, etc. a new 510k is not needed.

The intended use is not changing at all. But I would like to change the indications for use by removing the reference to specific model and brand of the device, substituting the general category of device but otherwise keeping the indications for use identical. the only possible way this changes the patient population is that the target market is increased numerically but not changed in terms of any definition of what an appropriate patient is.

I know that following the guidance document's flowchart literally results in having to file a new 510k. however, I think this is a minor change. the guidance document also states that "any change in the indications for use that limits use to within the currently cleared indication may occur without the submission of a 510(k)." The section of the guidance document that elaborates on the flowchart has this relevant statement:

"A1 Does the change affect the indications for use? .. any change in the indications for use that limits use to within the currently cleared indication may occur without the submission of a 510(k) .. If the expansion is to a population with similar demographics, diagnosis, prognosis, comorbidity and potential for complications as the original, then a new 510(k) is not ordinarily expected.

is it reasonable to document this but not file a new 510k? What's your opinion?
 
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MIREGMGR

Inactive Registered Visitor
#2
change the indications for use by removing the reference to specific model and brand of the device, substituting the general category of device
While I appreciate that you've evaluated the technical risks, that sounds like a broadening to me.

I'd think that, even with a rationale as to how it's 100% assured that the "general category" can't be different in any significant respect from the original clearance-target, you'd be exposed to the FDA differing with your borderline judgment call.
 

Mondo 22

Inactive Registered Visitor
#3
All,

If the brand name was to change on a product, would a new 510(k) or a change notification need to be submitted?

The indications for use shall stay the same.

Any other information on how this would affect other countries such as Australia, Canada and Japan would be greatly appreciated.

Thanks,
Ray
 

robert.beck

Quite Involved in Discussions
#4
So you're saying this is a "borderline" question? Let's assume it is a broadening of the indication, but that the worst case for the "broadening" is more of the same. Let's focus on this statement from the guidance document, "if the expansion is to a population with similar demographics, diagnosis, prognosis, comorbidity and potential complications as the original, then a new 510k is not ordinarily expected."

What would be a good way to document that the expanded indication is still the same patient population, especially given that this is an OEM product and therefore there is no readily available direct usage data?
 

MIREGMGR

Inactive Registered Visitor
#5
So you're saying this is a "borderline" question?
Yes, but notwithstanding your intended thread focus, my point had to do with the broadening from a specific reviewed device to a "category" of devices. If that "category" is less specifically defined than the reviewed filing, I think you might have a problem.

As to the "broadening of the indication":

What would be a good way to document that the expanded indication is still the same patient population, especially given that this is an OEM product and therefore there is no readily available direct usage data?
Not having any usage data seems to me to be a high hurdle to clear. All that I could suggest would be that whatever definitive pathway you used in the original filing, you exactly follow that same pathway in explaining how you can be sure that the population has not significantly changed.
 
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