CLIA (Clinical Laboratory Improvement Amendments) Waiver

S

Silvertabb

#1
Hello,
My understanding is that OTC device are automatically granted CLIA waiver. Devices used for HealthCare Professional must pass the required studies to show that they meet the CLIA waiver requirements.
Questions:
1) Is FDA reviewing the User Performance Study showing device is simple and the accuracy study information data included in the 510k to determine waiver?

2) If you already have a waiver for your predicate device and your new device being filed has the same intended use but advanced/different technological features, are you required to repeat the same studies done previously for the predicate for CLIA waiver?

3) How do you use the information listed under 42 C.F.R. § 493.15 Laboratories performing waived tests for CLIA?

I appreciate your response.
Sivertabb
 
Elsmar Forum Sponsor

Stijloor

Staff member
Super Moderator
#2
Hello,
My understanding is that OTC device are automatically granted CLIA waiver. Devices used for HealthCare Professional must pass the required studies to show that they meet the CLIA waiver requirements.
Questions:
1) Is FDA reviewing the User Performance Study showing device is simple and the accuracy study information data included in the 510k to determine waiver?

2) If you already have a waiver for your predicate device and your new device being filed has the same intended use but advanced/different technological features, are you required to repeat the same studies done previously for the predicate for CLIA waiver?

3) How do you use the information listed under 42 C.F.R. § 493.15 Laboratories performing waived tests for CLIA?

I appreciate your response.
Sivertabb
Suggestions anyone?

Thanks!!

Stijloor.
 
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