S
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
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