Who needs to apply for a CLIA waiver

[Jennifer27]

Dear Experts!

I am working with a IVD company which is creating an OTC glucose monitoring device to be used at home - the device needs a 510k clearance. Could you please guide me as to whether or not will it require CLIA waiver. Per my understanding, I think it should, but just to make sure.

Also, could you please let me know at which stage should the Manufacturer apply for CLIA waiver? Should it be after 510k clearance is obtained OR should that application be submitted as a part of 510k application. Should the manufacturer OR the test lab apply for CLIA waiver, whose responsibility is it?

Kindly advise,

Best,
Jen

 

[Jennifer27]

Can someone please help. Our company is making a blood glucose monitoring device. We are applying to the FDA only for 510k for blood glucose meter - the lancet and strips will be obtained from a 510k cleared supplier.