Medical Devices

CLIA Waiver by Application

 

What is a CLIA Waiver by Application?

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 or for over-the-counter 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

  1. Review the following guidances:
  2. Consider submitting planned protocols or study designs though the Pre-Submission process to obtain FDA’s feedback prior to conducting a clinical study to support a CW.
  3. Assemble the application. Recommended contents of a CW include, but are not limited to, the following:
    • A signed and dated cover letter that:
      • identifies the submission as a CW,
      • references a cleared/approved marketing application (e.g., 510(k), PMA, BLA), and
      • identifies at least one contact person, include name, title, phone number, and email address.
    • A description of the device that demonstrates it is simple to use.
    • The results of risk analysis including the identification of potential sources of error for your device.
    • The results of risk evaluation and control including a description of (1) measures you have implemented to mitigate the risk of errors, and (2) validation and/or verification studies demonstrating the ability of failure alert, fail-safe mechanisms, and other control measures that you have incorporated into your device to mitigate the risk of errors, even under conditions of stress.
    • The results of flex studies demonstrating insensitivity of the test system to environmental and usage variations under conditions of stress.
    • A description of the design and results of clinical studies you conducted to demonstrate that the device has an insignificant risk of erroneous result in the hands of the intended user, at intended use sites.
    • Proposed labeling with instructions for use consistent with a device that is "simple."
  4. Submit the application:
    CW submissions for in vitro diagnostic devices are reviewed by FDA’s Center for Devices and Radiological Health (CDRH), specifically, by the Office of In Vitro Diagnostics and Radiological Health (OIR). A CW submission package should be sent to CDRH’s Document Control Center (DCC). The current mailing address for CDRH’s DCC is provided on the eCopy Program for Medical Device Submissions webpage. To expedite review, the FDA strongly encourages submission of a validated eCopy.

FDA Actions on CLIA Waiver by Application Submission

  1. Email Acknowledgment Letter
    Within one week of the FDA’s receipt of the submission, the FDA will issue an email acknowledgment letter. The acknowledgment letter will include the date the FDA received the application and the assigned CW tracking number. The CW tracking number begins with the letters "CW" followed by 6 digits. The first two digits designate the calendar year the submission was received; the last four digits represent the submission number for the year, starting with 0001 (e.g. CW170001).
  2. Substantive Interaction (SI)
    The FDA will engage in a Substantive Interaction (SI) within 90 FDA review days. The SI may be an email or letter notifying the applicant that the CW has been Approved, the review will Proceed Interactively, or Additional Information is requested.
    • Proceed Interactively: the FDA has not identified substantive deficiencies in the initial submission review and any further minor deficiencies will be communicated through interactive review (email, phone, etc.).
    • Additional Information (AI): Additional Information is requested and the file is being placed on hold because substantive deficiencies were identified in the initial submission review.
      • In this case, the applicant should submit the information requested to the CDRH DCC as a supplement to the CW with 180 days.
      • If the FDA does not receive a complete response to all deficiencies in the AI request within 180 days of the date of the AI Request, the submission will be considered withdrawn and you will need to submit a new application.
  3. MDUFA Decision
    The FDA will issue a MDUFA Decision within 150 FDA days (320 FDA Days if an advisory panel is required). For CWs, a MDUFA Decision may be a notification of Waiver Approval, a notification of Waiver Denial, or withdrawal by the applicant. If the CW is approved, the waived categorization of the test will also be included in the public CLIA Database.
    ActionReview Time (FDA days) 
    Substantive Interaction90 days 
    MDUFA Decision
    No Panel
    With Panel
     
    150
    320
     
    Dual (510(k) and CLIA Waiver by Application180 

    The MDUFA goals for Substantive Interaction and MDUFA Decisions are defined in the MDUFA IV Commitment Letter. FDA Days are those calendar days when a submission is considered to be under review at the Agency once a submissions has been accepted. FDA Days begin on the date of receipt of the submission or of the amendment to the submission that enables the submission to be accepted.
  4. Missed MDUFA Decision
    If the FDA does not reach a MDUFA decision within 20 days after the MDUFA goal (i.e., 170 FDA days or 350 if an advisory panel is required), the FDA will issue a Missed MDUFA Communication. A Missed MDUFA Communication is written feedback to the applicant to be discussed in a meeting or teleconference, including the major outstanding review topic areas or other reasons that are preventing the FDA from reaching a final decision, with an estimated date of completion.

Dual Submission Pathway

A 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 that 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:

  • 510(k) SE and CLIA Waiver Approval
  • 510(k) SE and CLIA Waiver Denial
  • 510(k) NSE and CLIA Waiver Denial
  • Withdrawal by the Applicant

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 Summaries

The FDA is currently piloting the release of the CW decision summaries on our website. For additional information, see CLIA Waiver by Application (CW) Approval Determination Decision Summaries.

For questions or comments about the CLIA Waiver by Application Decision Summary Pilot, please contact CLIA@fda.hhs.gov.

Resources

Page Last Updated: 09/27/2018
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