Axim Biotechnologies Inc (AXIM)

[TexasMarvL]

FDA CLIA waiver guidelines. Review takes anywhere from 90 days to 320 days.. There is a FastTrack path for 510K/CLIA-WAIVER applications submitted together. 180 days.
Enjoy



https://www.fda.gov/medical-devices/ivd-regulatory-assistance/clia-waiver-application


Additionally Auer Precision is ISO-13485 certified.

Cut/Paste from link on page that opens a pdf:

"Administrative Procedures for CLIA Categorization - Guidance for Industry and Food and Drug Administration Staff "(PDF - 124KB)


A test initially categorized as moderately complex might meet the statutory criteria for CLIA
waiver if the device is simple to use and the sponsor demonstrates in studies conducted at the
intended use sites that the test is accurate and poses an insignificant risk of erroneous results. If a
Sponsor of a test categorized as moderate complexity believes their test meets the statutory
criteria for CLIA waiver, they may submit a CLIA Waiver by Application to request
categorization of the test system as waived. Such a submission should be mailed to the CDRH
Document Control Center (DCC) at the address listed above and identified as a CLIA Waiver by
Application submission. Note that all such submissions should be directed to CDRH, regardless
of the FDA Center responsible for the marketing review. To expedite review, FDA strongly
encourages submission of a validated eCopy per the Guidance Document “eCopy Program for
Medical Device Submissions.”

(http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocu
ments/UCM313794.pdf ).

CLIA Waivers by Application should reference a cleared/approved marketing application (e.g.,
510(k), PMA, BLA). As described in the MDUFA III and MDUFA IV Commitment Letters, an
applicant should inform FDA that it plans to submit a Dual 510(k) and CLIA Waiver application