To fully answer your question, we need to know more specifics about the Class II 510(k)-exempt system, and then also a precise description of the "add-on" and its intended use in order to understand the regulatory implications of the "add-on".
For example, if the "add-on" is just a "component" [21 CFR 820.3(c)] and doesn't affect the system's 510(k)-exempt status, then no further registration or listing is required for such a component.
But your explanation seems to indicate that the "add-on" may have a different product code than the parent/affiliated system. If so, then definitely yes, the add-on's product code needs to be added to your FDA FURLS device listings. This could be the case for example regarding an "add-on" that meets FDA's understanding of "accessory", or got a component sold as a finished device. Again, we'd need to know more details, as those details can have a profound impact on the associated regulatory responsibilities.
FDA has a DRLM guidance that includes creation of device listings for when such listings need to be created.
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Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
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Original Message:
Sent: 04-Oct-2023 14:15
From: Anonymous Member
Subject: Class II 510k Exempt - Need to List Device in FURLS DRLM?
This message was posted by a user wishing to remain anonymous
We are creating an add-on to our existing system that is considered Class II 510k Exempt by the FDA.
Do I still need to add the product code to our FDA FURLS device listing?
If I do need to add a product code... does anyone have guidance on how to do that in the FURLS system? I've only ever had product codes added automatically when the FDA accepted our 510ks!