Change to labelling - does it require a new 510(k)?

[Drgale]

I have a question regarding a change in labelling for an FDA cleared device.
If during Post market feedback a new risk has been identified, therefore resulting in an added precaution on the IFU, that however does not change the intended use or instructions for use.
Would this require a new 510(k)?

Thanks!

 

[Watchcat]

A precaution advises provider and/or patient of specific circumstances of use under which use of the product might pose additional risk relative to other circumstances of use within the scope of its intended use. How provider and patient adjust their use under the precaution is usually left to them to decide, but a precaution can be expected to change use, or there would be no point in including it.

I'm not sure about your statement that adding a precaution to the IFU does not change the instructions for use. IFU = instructions for use. If you add something to the IFU, you have added something to the instructions for use. An addition is a change. Perhaps you meant indication for use. I don't want to get into the difference between intended use and indication for use, because I think this is a swamp. Maybe someone else has their hip boots on and will be happy to wade in.

I also don't want to advise you regarding the need for a 510(k), nor what flavor of 510(k) you might submit. Just want to disagree with the notion that you can add a precaution on use of the product without changing its use, whatever you want to call it...intended, indication, instructions for.

 

[Ed Panek]

We utilize a form based on FDA guidance

A1
Does the change affect the indications for use statement?
Yes – See A1.1 / No – See Question A2
A2
Does the change add or delete a contraindication?
Yes -New 510K / No – See Question A3
A3
Is this a change in the warnings or precautions?
Yes – See A1.1 / No – See Question A4
A4
Could the change affect the directions for use?
Yes – See A1.1 / No – Documentation
A1.1
Is it a change from a device labeled for single use only to a device labeled as reusable?
Yes – New 510K / No – See Question A1.2
A1.2
Is it a change from Rx to over the counter OTC use?
Yes – New 510K / No – See Question A1.3
A1.3
Is it a change to the device name or to solely improve readability or clarity?
Yes – Documentation / No – See Question A1.4
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?
Yes – Documentation / No – See Question A1.5
A1.5
Does a risk-based assessment identify any new risks or significantly modified existing risks?
Yes – 510K see chart / No – Documentation​

 

[Watchcat]

We utilize a form based on FDA guidance

I think the No under A3 should direct you to Question A1.4, not A4?

 

[Drgale]

Hi and thanks for the answers. I went also through the guidance and I end up with documentation. However I am not really sure if this at all applies to my situation. The change made does not change the indication (thanks Watchcat) and doesn't introduce any new risks, all other parameters are in the cleared range. However, the change made results in a product variant to the main product e.g. one part is 2mm longer than in the main product. The product variant has also a slight change in the name as well... does this also fall under the the same guidance? Because yes it is a change to the preduct but results in a new product variant (under the same product family)

 

[Ed Panek]

Is this 2mm longer product specific for a user population that should not purchase the 2mm shorter version?