Wednesday, March 13, 2024 6:43:59 PM
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
Recent AXIM News
- Form 10-Q/A - Quarterly report [Sections 13 or 15(d)]: [Amend] • Edgar (US Regulatory) • 05/22/2024 08:53:56 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/20/2024 08:24:40 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 12/28/2023 04:59:09 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 11/20/2023 09:29:50 PM
- Form DEF 14C - Other definitive information statements • Edgar (US Regulatory) • 09/21/2023 03:07:21 PM
- Form PRE 14C - Other preliminary information statements • Edgar (US Regulatory) • 08/31/2023 08:10:23 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/21/2023 05:35:50 PM
- Form NT 10-Q - Notification of inability to timely file Form 10-Q or 10-QSB • Edgar (US Regulatory) • 08/14/2023 08:11:37 PM
Glidelogic Corp. Becomes TikTok Shop Partner, Opening a New Chapter in E-commerce Services • GDLG • Jul 5, 2024 7:09 AM
Freedom Holdings Corporate Update; Announces Management Has Signed Letter of Intent • FHLD • Jul 3, 2024 9:00 AM
EWRC's 21 Moves Gaming Studios Moves to SONY Pictures Studios and Green Lights Development of a Third Upcoming Game • EWRC • Jul 2, 2024 8:00 AM
BNCM and DELEX Healthcare Group Announce Strategic Merger to Drive Expansion and Growth • BNCM • Jul 2, 2024 7:19 AM
NUBURU Announces Upcoming TV Interview Featuring CEO Brian Knaley on Fox Business, Bloomberg TV, and Newsmax TV as Sponsored Programming • BURU • Jul 1, 2024 1:57 PM
Mass Megawatts Announces $220,500 Debt Cancellation Agreement to Improve Financing and Sales of a New Product to be Announced on July 11 • MMMW • Jun 28, 2024 7:30 AM