Under
CLIA, FDA categorizes in vitro diagnostic (IVD) tests by their degree of complexity: waived, moderate complexity, and high complexity. Tests that are waived by regulation under 42 CFR 493.15(c), or cleared or approved for home use, are automatically categorized as waived following clearance or approval. Otherwise, following clearance or approval,
tests may be categorized either as moderate or high complexity according to the CLIA categorization criteria listed in 42 CFR 493.17. A manufacturer of a test categorized as moderate complexity may request categorization of the test as waived through a CLIA Waiver by Application (CW) submission to the FDA. When a test is categorized as waived, it may be performed by laboratories
with a Certificate of Waiver. In a CW submission, the manufacturer provides evidence to the FDA that a test meets the CLIA statutory criteria for waiver, 42 U.S.C. § 263a(d)(3). The statute states that: The examinations and procedures [that may be performed by a laboratory with a Certificate of Waiver] are laboratory examinations and procedures that have been approved by the Food and Drug Administration for home use or that, as determined by the Secretary, are simple laboratory
examinations and procedures that have an insignificant risk of an erroneous result, including those that — (A) employ methodologies that are so simple and accurate as to render the likelihood of erroneous results by the user negligible, or (B) the Secretary has determined pose no unreasonable risk of harm to the patient if performed incorrectly. How to Prepare a CLIA Waiver by Application
FDA Actions on CLIA Waiver by Application Submission
Dual Submission PathwayA Dual 510(k) and CLIA Waiver by Application (Dual Submission) is a single submission containing a complete 510(k) and CLIA Waiver by Application package. A Dual Submission is subject to 510(k) eCopy requirements, requires a 510(k) MDUFA User fee, and is subject to 510(k) Refuse to Accept (RTA) policies. An applicant should inform the FDA they plan to submit a Dual Submission through a Pre-Submission, and the cover letter for a Dual Submission should reference this Pre-Submission number. The Pre-Submission process provides a forum for the sponsor and the FDA to discuss proposed study designs for the Dual Submission. The Substantive Interaction for a Dual Submission should occur within 90 FDA Days and applies to the complete Dual Submission. The FDA goal to make a MDUFA Decision for a Dual Submission is 180 FDA Days (320 FDA Days if an advisory panel is required). MDUFA Decisions for a Dual Submission include:
Please see the following guidance for study design recommendations for Dual Submissions:
Is there a User Fee for a CLIA Waiver by Application?There is no MDUFA User Fee for a CLIA Waiver by Application. Please note for the Dual Submission Pathway, you must pay the MDUFA User Fee for the 510(k) application. CLIA Waiver by Application Decision SummariesSince 2017, the FDA has made CW decision summaries available on our website. For additional information, see CLIA Waiver by Application Decision Summaries. Resources
Which of the following is a CLIA waived test that can be performed by the medical assistant quizlet?HCT is a hematocrit, also referred to as packed cell volume. This is a measure of the percentage volume of red blood cells in a sample of whole blood. It is considered a waived test by CLIA standards.
Which test is a CLIA waived test?As defined by CLIA, waived tests are “simple laboratory examinations and procedures that have an insignificant risk of an erroneous result.” Examples of waived tests include: dipstick urinalysis, fecal occult blood, urine pregnancy tests, and blood glucose monitoring.
Which of the following tests are CLIA waived and may be performed in the pol?Waived tests are simple, one-step tests approved by CLIA for use in a physician's office laboratory. The government requires a certificate of waiver to perform waived tests. Some waived tests include glucose monitoring, urine dipstick analysis, pregnancy testing, and fecal occult blood packets.
Is a CBC a CLIA waived test?The Food and Drug Administration (FDA) has granted premarket clearance and a CLIA waiver to Sysmex America for its complete blood cell count (CBC) test, the XW-100 Automated Hematology analyzer.
|