FDA Device Listing Question - "Each Device" Definition - 21 CFR Part 807

[singber]

The regulation for device listing (21 Part 807) states "The identification by classification name and number, proprietary name, and common or usual name of each device being manufactured, prepared, propagated, compounded, or processed for commercial distribution that has not been included in any list of devices previously submitted on form FDA-2892."

My company is struggling with the term each device. We produce several devices (software products) that all fall under the JQP (calculator/data processing module, for clinical use) product code.

Would each one of these products be considered a unique device that has to listed, or since they are all under one product code, would only one need to be listed?

Any advice (including references from the FDA) would be helpful.

 

[MIREGMGR]

I can't provide relevant FDA guidance, but it's common industry practice to combine into a single Listing a group of closely related products that:

1. From the quoted statement above, have the same classification name and number, the same proprietary name, and the same common or usual name.
2. Have the same intended use.
3. Differ only in regard to dimensions, color, or similar family characteristics.

 

[GPjeri]

Check the FURLS info on the FDA site; it provides step by step and answers your question.

 

[singber]

Thanks, I looked through the FURLS information but didn't see anything addressing the specific scenario I described above.

 

[wangyang]

Thanks, I looked through the FURLS information but didn't see anything addressing the specific scenario I described above.

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I think both way(list the simialr device and list each device) is acceptable, if you serach for the FURLS database, you can find both senorios which have exist for many years.