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===Scratch pad for updated POL guide=== | |||
* More information can be found regarding the CLIA complexity levels and what is required under each on the [http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/IVDRegulatoryAssistance/ucm393229.htm FDA's website], the references in this section, and the [http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/analyteswaived.cfm CLIA waived test list]. | |||
<ref name="FDAClin21">{{cite web |url=https://www.fda.gov/medical-devices/medical-device-databases/clinical-laboratory-improvement-amendments-download-data |title=Clinical Laboratory Improvement Amendments - Download Data |publisher=U.S. FDA |date=23 November 2021 |accessdate=18 April 2022}}</ref> | |||
* <ref name="FDAClin21">{{cite web |url=https://www.fda.gov/medical-devices/medical-device-databases/clinical-laboratory-improvement-amendments-download-data |title=Clinical Laboratory Improvement Amendments - Download Data |publisher=U.S. FDA |date=23 November 2021 |accessdate=18 April 2022}}</ref> | |||
* https://www.aacc.org/advocacy-and-outreach/position-statements/2021/modernization-of-clia-certificate-of-waiver | |||
* https://www.jhconline.com/the-value-in-lab.html | |||
Revision as of 21:35, 25 April 2022
Scratch pad for updated POL guide
- More information can be found regarding the CLIA complexity levels and what is required under each on the FDA's website, the references in this section, and the CLIA waived test list.
- ↑ "Clinical Laboratory Improvement Amendments - Download Data". U.S. FDA. 23 November 2021. https://www.fda.gov/medical-devices/medical-device-databases/clinical-laboratory-improvement-amendments-download-data. Retrieved 18 April 2022.
