Regulatory Open Forum

Hello Thomas

I've never tried that, but as you say, there is logic behind the idea, so it could be made to work.

Currently, for this one contraption, I guess there are two model numbers, two UDIs, two GMDN codes, two 510(k)s, two risk assessments, two usability files, two IFUs, two labels.

One approach might be to make a whole new model number, new UDI, new GMDN code, new risk assessment, new usability file, new label, maybe a new IFU, and a new 510(k).

It sounds like the company wants to do something more like selling one of the already cleared devices along with the labeling from the other cleared device, perhaps with some additional labeling saying something like "model number(s) intended for uro-gyne use".

To begin, this would want some usability risk assessment. Like what could go wrong if the users get some aspects of the two IFUs mixed up?

If you want to try it without a new 510(k), next I'd work through the guidance on deciding whether the claims (e.g. dual-use) are consistent with the FDA-cleared labeling. And of course work through the guidance on deciding whether a change requires a new 510(k). That might lead you to a clear answer, or at least it should show where the difficulties may be.

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Anne LeBlanc
United States
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Original Message:
Sent: 21-Dec-2021 19:46
From: Thomas Lawson
Subject: Distributing a device that has 2 different uses

A company has a cystoscope cleared for urological use via a 510(k) and then we took that exact same scope and sent it to the OBGYN section of CDRH and just received clearance for it to be used as a hysteroscope. Again, both are the exact same device but now with 2 different intended use statements. Marketing wants to position both uses of the exact same scope to Uro-Gynecologists so that when they have a cystoscopy they can use it and when they have a hysteroscopy they can use it. Obviously labeling-- both IFUs and pouch labels-- are different. So, is it possible to combine the two into a uro-gyne device? Certainly it would be clear that if the use is urological read IFU A and if the use is gynecology read IFU B, but does anyone have experience in such a situation?

HI Thomas, can you please clarify if it's one company with 2 clearance in different divisions or two companies with separate clearances in Uro and OBGYN?

In any case, it is possible and I have experience such situation.   We have one device with two different intended use cleared and we have done both combining IFU and labels as well as 2 IFUs (including the two intended use) with 1 label.  However, my experience is related to one company with 2 clearances on the same device.

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Winkie Wong
Manager, Regulatory Affairs
El Segundo CA
United States
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Original Message:
Sent: 21-Dec-2021 19:46
From: Thomas Lawson
Subject: Distributing a device that has 2 different uses

A company has a cystoscope cleared for urological use via a 510(k) and then we took that exact same scope and sent it to the OBGYN section of CDRH and just received clearance for it to be used as a hysteroscope. Again, both are the exact same device but now with 2 different intended use statements. Marketing wants to position both uses of the exact same scope to Uro-Gynecologists so that when they have a cystoscopy they can use it and when they have a hysteroscopy they can use it. Obviously labeling-- both IFUs and pouch labels-- are different. So, is it possible to combine the two into a uro-gyne device? Certainly it would be clear that if the use is urological read IFU A and if the use is gynecology read IFU B, but does anyone have experience in such a situation?