Listing Exempt Medical Devices with the USFDA

M

Mike_Benz

#1
All,

We are beginning to list all of our Class I/ Class II products with the USFDA, which I have broken into 2 groups:
1 - exempt
2 - 510 clearance

This questions regards those items in Group 1 - Exempt from needing 510k clearance.

Our HQ out of the USA (registered with the USFDA as specification developer/ relabeler) through our sister company in China (manufacturer of record, ISO and NOT registered with the USFDA) has supplier agreements with a handful of GMP factories within the various provinces throughout the country, who CM for us.

I will break these factories into 2 groups:
a - registered with the USFDA (very few)
B - not registered with the USFDA (many)

Here's are my questions:
For Factories in Group B (not registered) can we:
a - List the exempt goods on our USFDA DRLM, as this is self-generated and they do not asked for the manufacturer
b - If not, can be registered our China sister company with the USFDA, and simply list our China office as the manufacturer (note: they are NOT the end manufacturer, only the manufacturer of record with the supplier agreements, whom we can name relabeler/ specification developer if need be).

Basically, if the above was confusing: Can we list exempt goods from factories NOT registered with the USFDA on our FDA company database (DRLM)??

thank you so much!

Best,

Mike
 
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