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Expanding the indications for use for a 510(k) cleared device

#1
Hello,

I am here to look for some advice from anyone who has had a similar experience or suggestions.

We received 510k clearance for our device a while ago, however, the approved indications for use were broad terms such as improve local blood flow circulation and relief of muscle pain. We later conducted tests and researches would like to market our device with a new indication for use: wound healing. We can tell from clinical aspects and from physiology that increasing local blood flow wound is beneficial for wound healing, but we are not sure if this is available without filing a traditional 510k to alter the indications for use.
And if without altering, can we passively provide (actively is prohibited for sure lol) this "off-label use" information, such as scientific research or journal publications, to consumers?

Does anyone have experience with this?

Many thanks for reading.
 
Elsmar Forum Sponsor
#4
I don't know the details and have all the info, but it does appear like this would be an expansion of the indications for use that would require a submission.

Here's the FDA Guidance document that should explain your question regarding providing information about off-label uses.
Thank you!
I came through this guidance document as well and it seems that it is better to do a submission for the expansion or else it is very difficult to do any kind of explanation to the consumers.
 
#5
From the 2017 FDA guidance doc regarding when to submit for a new 510k based off changes to an existing device found here: https://www.fda.gov/media/99812/download, we can follow the decision tree in the labeling section to question A1: Changes to Indications For Use -> to A1.4: "Does the change describe a new disease, condition, or pt pop that the device is intended in diagnosing, treating, preventing, curing or mitigating?"

Since the answer to that would be yes, as you describing a new condition to be treated, it would trigger a new 510k.

However, that being said, because it is an existing device it would follow the Special 510k pathway for an existing device as opposed to a traditional 510k.
 
#6
Hi there,

This looks like a good scenario where another type of 510(K) submission can be considered:

According to the latest Special 510(K) program finalized in 2019, FDA no longer restricts Special 510(K) submission if a manufacturer wants to make modifications to Indications of use within the intended use. FDA accepts certain modifications if their guiding principles are met. Below is the summary in reference to the change proposed above:

1) Is the change to Manufacturer's own device? - From the information above, It looks like a Yes.

2) Is Performance data required to evaluate the change? - As indicated above, tests were conducted. See if these test results are sufficient to support SE. If not, see if the design control procedures/ FDA's guidance documents or consensus standards help demonstrate the SE.

3) Is there a well-established method available to support this change? - Well-established methods may include use of FDA's consensus standards, guidance document, manufacturer's own DC procedures/protocols, acceptance criteria, scientific lit etc. It seems like there may be well-established methods available to support this modification.

4) Can the data be reviewed in Summary or risk-analysis format? - Can the data collected to support the SE be reported in concise manner in form of Summary or Risk Analysis vs needing to provide full test reports to demonstrate SE.

Hope this helps,
Heena
 
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