FDA Updates Their CLIA Waiver Process

Jul 20, 2023 | News |

The FDA has updated their CLIA Waiver Process in the following ways: 

CLIA Waiver by Application 

The FDA has updated its CLIA waiver process to provide manufacturers of in vitro diagnostic (IVD) tests with clearer guidelines and requirements. Under the Clinical Laboratory Improvement Amendments (CLIA), IVD tests are categorized as waived, moderate complexity or high complexity. Tests that are cleared or approved for home use are automatically categorized as waived, while others may be categorized as moderate or high complexity. Manufacturers of tests initially categorized as moderate complexity can now request a CLIA Waiver by Application (CW) submission to the FDA to have their test categorized as waived. The manufacturer needs to provide evidence to the FDA that the test meets the statutory criteria for waiver, including employing methodologies that are simple and accurate or posing no unreasonable risk of harm to the patient. The FDA will engage in a Substantive Interaction (SI) within 90 FDA review days, during which they may request additional information or proceed interactively with minor deficiencies. The FDA will then issue a MDUFA Decision within 150 FDA days, determining whether to approve or deny the waiver. 

CLIA Waiver by Application Decision Summaries 

Since 2017, the FDA has made CW decision summaries available on its website, allowing the public to understand how the FDA reviewed an applicant’s data to make a CW approval determination. These decision summaries provide insights into the types of studies conducted by other applicants and offer useful information for manufacturers preparing future CW submissions. Manufacturers can learn from the summaries and conduct similar flex studios and clinical studies to support their applications. The CW decision summaries aim to enhance transparency and facilitate the process for manufacturers seeking CLIA waivers. 

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For a more detailed look into the updates to the CLIA Waiver Process, check out the links below! 

References 

  1. CLIA Waiver by Application | FDA 
  2. CLIA Waiver by Application Decision Summaries | FDA 

Ava Carr – Content Creator