Private Label CLIA Waived Status

M

ManTheDan88

#1
My company is looking to buy a test that has a CLIA status of waived under the manufacturer's product name. If the manufacturer were to private label the test to us, would we have to apply for CLIA waiver under the new device name? If so, would we have to conduct the clinical trials or is registering and listing the device with "xxxxxx" as the manufacturer sufficient?

Also, the test is supposedly grandfathered by the FDA as it is a Class I device. There is no 510k on the product but the manufacture has assured us that we can market the product in the US.

Thanks for all of the help. :thanx:
 
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I

IVD_RA

#3
Manthe Dan88,

I do not think your comapany has to conduct or apply for CLIA waiver application if you are the private label manufacturer. whose address will be on the labels as Manufacturer for the test? who owns the regulatory filing? depends upon these answers, your comany might not need to do anything for regulatory complaince onlly quality agreement and peroidic audit is required.

Hope this helps
 
M

ManTheDan88

#4
My company's address will be on the labels and the manufacturer is the one that owns the regulatory filing.
 
U

USCTrojan83

#5
Dan,

I have some experience in the IVD CLIA Waived FDA dealings, especially when dealing with OEM private labels.

1. I dont believe there is any "grandfathering" clause with the CLIA complexity guidlines. It would be helpful to know what product this is. Also CLIA waivers werent established until 1992 for things like pregnancy tests, iFOBT, URS, etc. Im unaware of any company that hasnt filed for a waiver that didnt already have a 510(k) clearance.
2. If the manufacturer of the device is going to OEM their device in your name/brand, they are required to send a "Letter to File/Add to File", which is a letter addressed to CLIA, and includes a comparison of intended use, indications, IFUs, labeling, design etc. Also it would include examples of all the labeling (primary and secondary) for the OEMed device.
3. You WANT a letter from the FDA granting the CLIA Status (waived or moderate complexity). I would not start distributing that device until you have a response letter from the FDA CLIA Board granting clearance of the OEM prior to selling.

Do you need this clearance/letter from CLIA? No not necessarily. But if you dont and the "Grandfathered" device claim doesnt hold its weight in water, well then you may be staring at a massive recall of thousands, if not hundreds of thousands of devices.

CLIA keeps a list of available waived, moderate and high complexity devices which can be found on the 510k database page. If your device isnt listed there, then it isnt CLIA recognized. You get on the list by performing the "Add to File" above.

Good luck
 
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