Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

We are making some design changes to a product and I was looking for some guidance regarding liklihood of acceptance of special 510(k) versus requiring a traditional 510(k).  Does anyone have any experience with regards to material changes being submitted through special 510(k) and if FDA has required them to be converted?  Per the guidance document on special 510(k) it states that formulation changes are okay, but that new material types should have been used in a product in same classification.  Our original product was approved under de novo, so we are the only device within the classification.  If we did not use a material in our predicate device, does it automatically trigger a traditional 510(k)?  Anybody that has experience with submission of special 510(k) and experience with it being converted and what triggered the conversion that would be willing to share their experience, would be greatly appreciated.  Thank you.

If the new material is used in a similar manner or contacts similar tissue you may be okay without the predicate. Regardless, a conversion from a special to a traditional by the FDA is not a big deal and if you are prepared for that possibility it shouldn't be an issue. It will change your review timeline and the FDA will likely ask for full test reports for certain tests that could be affected by the material change. Feel free to send me a message if you want more specific advice, I've dealt with several of these at both the FDA and in industry.

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Michael Nilo
Network Regulatory Partners
Nilo Medical Consulting Group
Portland OR
United States
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Original Message:
Sent: 12-Jun-2017 12:11
From: Anonymous Member
Subject: Special 510(k) versus Traditional 510(k)

This message was posted by a user wishing to remain anonymous

We are making some design changes to a product and I was looking for some guidance regarding liklihood of acceptance of special 510(k) versus requiring a traditional 510(k).  Does anyone have any experience with regards to material changes being submitted through special 510(k) and if FDA has required them to be converted?  Per the guidance document on special 510(k) it states that formulation changes are okay, but that new material types should have been used in a product in same classification.  Our original product was approved under de novo, so we are the only device within the classification.  If we did not use a material in our predicate device, does it automatically trigger a traditional 510(k)?  Anybody that has experience with submission of special 510(k) and experience with it being converted and what triggered the conversion that would be willing to share their experience, would be greatly appreciated.  Thank you.

Generally this depends on a couple of specifics. For instance, is the material patient contacting? If so, that will often trigger FDA to ask for a traditional 510(k). Not always (except on implants), if, perhaps there are other devices that use the material in the same type/duration of contact that can be referenced.

Also, is the material integral to the performance of the device? In the past I have seen that if the material is largely cosmetic, or is not critical to quality for any performance feature, these can go through a Special 510(k). However, if the material can potentially impact performance a Traditional 510(k) was required. For instance, if the device required a tensile strength of a certain level, a change of plastic materials could clearly impact function.

g-

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Ginger Glaser RAC
Vice-President, Quality and Regulatory Affairs
Maplewood MN
United States
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Original Message:
Sent: 12-Jun-2017 12:11
From: Anonymous Member
Subject: Special 510(k) versus Traditional 510(k)

This message was posted by a user wishing to remain anonymous

We are making some design changes to a product and I was looking for some guidance regarding liklihood of acceptance of special 510(k) versus requiring a traditional 510(k).  Does anyone have any experience with regards to material changes being submitted through special 510(k) and if FDA has required them to be converted?  Per the guidance document on special 510(k) it states that formulation changes are okay, but that new material types should have been used in a product in same classification.  Our original product was approved under de novo, so we are the only device within the classification.  If we did not use a material in our predicate device, does it automatically trigger a traditional 510(k)?  Anybody that has experience with submission of special 510(k) and experience with it being converted and what triggered the conversion that would be willing to share their experience, would be greatly appreciated.  Thank you.