M
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
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