Sponsors may submit a CLIA Waiver by Application if they think the FDA has mistakenly categorized their test. For example, if the FDA initially categorized a test as moderately complex, but the sponsor believes the test is simple to use, the sponsor may submit a CLIA Waiver by Application to request re-categorization as Waived. A CLIA Waiver by Application must demonstrate in clinical studies conducted at the intended use sites that the test is accurate and poses little to no risk of incorrect results.
A CLIA Waiver by Application submission should include the following information.
- A description of your 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 flex studies demonstrating insensitivity of the test system to environmental and usage variations under conditions of stress.
- 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.
- A description of the design and results of clinical studies you conducted to demonstrate that the device has an insignificant risk of erroneous results in the hands of the intended user (hereinafter operator).
- Proposed labeling with instructions for use consistent with a device that is "simple."
Detailed submission requirements are described in in FDA’s guidance "Recommendations: Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices."
Prior to conducting a clinical study to support a CLIA Waiver by Application, sponsors are encouraged to submit their planned protocols or study designs though the Pre-Submission process to obtain FDA’s feedback. The Pre-Submission process provides a forum for the sponsor to obtain feedback from the FDA on what information should be included in the CLIA waiver application.
A "Dual 510(k) Waiver by Application (Dual)" is a single submission package requesting 510(k) clearance and CLIA Waiver categorization. Under the Dual program the 510(k) and the Waiver by Application must be submitted as a single package at the same time. Per the MDUFA III Commitment letter, prior to submission of a Dual, sponsors must come to the FDA with a Pre-Submission. The Pre-Submission process provides a forum for the sponsor and the FDA to come to an agreement on what information should be included in the Dual application. This process may help speed the acceptance of a Dual Submission by ensuring all necessary information is provided in the submission package.
The Dual program is only applicable to 510(k) applications, not Pre-Market Applications (PMAs) or de novos.
Performance goals for CLIA Waiver by Applications filed from FY 2013 through FY 2017 (MDUFA III) are defined as follows in the MDUFA III Commitment Letter.
FY2013 – FY2017
|Dual (510(k) and CLIA Waiver by Application) ||210||90%|
A Substantive Interaction may be a request for Additional Information (via email), a notification that review will Proceed interactively (via email), or a notification of Waiver Granted (via email). A MDUFA Decision may be a notification of Waiver Granted (via email), notification of Wavier Denial (via email), or withdrawal by the sponsor. The goals for Substantive Interaction and MDUFA Decisions are in terms of FDA Days, which are defined in the MDUFA III Commitment Letter as those calendar days when a submission is considered to be under review at the Agency for submissions that have been accepted. FDA Days begin on the date of receipt of the submission.
Administrative Procedures for CLIA Categorization - Guidance for Industry and Food and Drug Administration Staff
- Final Guidance: Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff (PDF - 297KB)
- Pre-submission Process
- MDUFA III Commitment Letter (PDF - 156KB)