Is FDA Establishment Registration required for clinical manufacturing ?

SGquality

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If a facility manufactures samples for Clinical samples, is it required to be FDA Establishment Registered ?

My understanding was only for commercial manufacturing but our customer differs on this.
 

Stijloor

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V

Vthouta

It's purely customer driven. Recently, one of our customer wanted us to be FDA registered for making the clinical samples. We were listed as the only manufacturer for these samples. This was the case of a startup. Being a start-up, they had to partner and list our manufacturing facility as part of FDA approval process for one of their medical device.

I'm not sure for the commercial establishment, but my firm builds lot of product lines for well-known reputed companies, but we are not listed as one of their FDA registered sites.

Thanks,
Vikram
 
M

MIREGMGR

If a facility manufactures samples for Clinical samples, is it required to be FDA Establishment Registered ?

My understanding was only for commercial manufacturing but our customer differs on this.

If you're asking in regard to pharma, and if by "clinical samples" you mean product that will be used on humans such as in clinical trials, my understanding is that you must be Registered.

If you're asking in regard to devices, and the products you make are for use on humans including in clinical trials and are substantially ready for use when they leave your facility, you definitely must be Registered.

I'm not sure for the commercial establishment, but my firm builds lot of product lines for well-known reputed companies, but we are not listed as one of their FDA registered sites.

There is no exception in the registration rules for firms that make "clinical samples". If a product meets the definition of a medical device, including medical devices to be used in clinical trials, the maker must be Registered. See the categories "Manufactures a Custom Device" and "Contract Manufacturer" at https://www.fda.gov/MedicalDevices/...urDevice/RegistrationandListing/ucm053165.htm.
 
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