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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.
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.
