Special 510(K) - Labeling change from Rx to OTC

Sourav

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#1
If a manufacturer is interested to get a clearance for a labeling change from Rx to OTC can this be done through a special 510(k)? This is the only change that is being done to the device which was cleared earlier by the FDA for home use and there are absolutely no design changes that are being done to the device. To be able to support the OTC the manufacturer is working on Human factors validation study.
 
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shimonv

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#2
Hi Sourav,
Have a look at the FDA guidance on The Special 510(k) Program.
In a nutshell, you are changing the intended user and intended environment. You need to submit perfromance data such as human factors validation study to support this change. The perfromance data needs to be in accordance with a well established method.

The FDA guidance says:
"To be appropriate for a Special 510(k), the results from verification and validation associated with design or labeling changes should be able to be placed in a summary or risk analysis format without losing information necessary to support SE."

I am doubtful that a summary of a human factors study is sufficient to support substantial equivalence. Furthermore, you many need to change somethings in the IFU or the device itself to make it suitable for OTC.

Shimon
 

Sourav

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#3
Hi Shimonv,

Thanks for your thoughts!

I did go through the FDA guidance on the special 510(k) program.

Regarding the Intended User and Use environment - It still remains the same as the Rx device has been cleared for Home use already.

Regarding Summary of performance - According to the guidance a summary of the performance data means conditions where the agency does have to interpret the raw data, like images, graphs, statistical data. We would be providing the results of the Human Factors validation study after analysing and interpreting the data internally.

As I have mentioned earlier there is absolutely no design change to device that is already cleared.
 

shimonv

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#4
Okay.. I guess I misunderstood you. If your device has already been cleared for home use why are you doing a human factors validation study? and when you write about labelling change, do you mean IFU, device label or both?

Shimon
 

monoj mon

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#5
This will depend on how well you prepare your "Risk Analysis" document to support the changes. You will need to identify a well-established method to evaluate the changes. But, I doubt to some extent, FDA may consider it as change in the "Intended Use" based on discussions in this thread where the FDA rejected the submission as the Predicate was "Rx Only" while the subject device was "OTC". However, it is worth a try to submit it via a special 510(k). You have nothing to lose, except it will take two more additional months if it is converted to a traditional 510(k).
1589446751685.png
 
Last edited:

Sourav

Posts Moderated
#6
Okay.. I guess I misunderstood you. If your device has already been cleared for home use why are you doing a human factors validation study? and when you write about labelling change, do you mean IFU, device label or both?

Shimon
Okay so let me explain you the exact situation.

The device has been cleared for home use and is being used at home conditions but by the order of a physician hence a Rx Device in the US. All the other regions the device is being sold as OTC.

Now the manufacturer wants OTC clearance for the US as well. There are no such predicate device cleared for OTC as the subject device.

RX to OTC is a changes to the Indications for Use and in turn a labeling change.

Here is a similar example that I found on the Guidance.

1589448601973.png
 

shimonv

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#7
Okay, now I understand better :)
The example you provided is perfect for special 510(k). EMC testing is a well established method and often performed by a third party lab.
And, as you probably noticed, they give allowance to change the environment; not the intended user.
In essence, you are taking the decision making or treatment away from the healthcare professional and giving it over to the lay person.
FDA doesn't "swallow" such things easily.

With therapeutic devices, I've seen cases where the manufacturer developed a less powerful device for the home use.
With diagnostic devices, I've seen cases were the manufacturer changed the device and/or labelling to address concerns for misinterpretations.

I am all for shortcuts, but this is a tough one and even more so since you wrote that there is no predicate device approved for OTC.

Shimon
 

Sourav

Posts Moderated
#8
Okay, now I understand better :)
The example you provided is perfect for special 510(k). EMC testing is a well established method and often performed by a third party lab.
And, as you probably noticed, they give allowance to change the environment; not the intended user.
In essence, you are taking the decision making or treatment away from the healthcare professional and giving it over to the lay person.
FDA doesn't "swallow" such things easily.

With therapeutic devices, I've seen cases where the manufacturer developed a less powerful device for the home use.
With diagnostic devices, I've seen cases were the manufacturer changed the device and/or labelling to address concerns for misinterpretations.

I am all for shortcuts, but this is a tough one and even more so since you wrote that there is no predicate device approved for OTC.

Shimon
Okay that sounds reasonable

However I would like to continue the debate, hope you dont mind.

If I would say in one of my recent clinical trial which was designed to use the device for a more duration than what it is cleared for and we did not see any side effects or adverse events that could have even close to a life threatening risk. and in terms of risk i would say the device is definitely very very safe and have proven results for the same.

Now what would be your thoughts on the process.
 

shimonv

Trusted Information Resource
#9
I would say good argument... but not for a Special 510(k).
The special 510(k) program, as I understand it, is suitable for a very narrow type of changes.

I think you owe me chocolate :)

Shimon
 

Sourav

Posts Moderated
#10
I would say good argument... but not for a Special 510(k).
The special 510(k) program, as I understand it, is suitable for a very narrow type of changes.

I think you owe me chocolate :)

Shimon
Thanks for all your time and inputs. I definitely owe you a bigger argument ;). I ll come back if I find something useful.
 
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