Labeling: Laboratory Developed Tests FAQs
A: For IVDs that fall within the enforcement discretion policies for NYS CLEP, unmet needs, or “currently marketed IVDs offered as LDTs” (i.e., those first marketed before May 6, 2024), where FDA is intending to exercise enforcement discretion for premarket review, FDA intends to request that manufacturers submit labeling information to the Agency in connection with the listing of the IVD as provided in 21 CFR 807.26(e). FDA intends to provide further instructions regarding the submission of such labeling information at a later date. As described in the preamble to the LDT final rule, labeling includes IVD performance information and a summary of supporting validation, as applicable. In particular, this information will help FDA more closely monitor IVDs offered as LDTs under these enforcement discretion policies, and identify those that may lack analytical validity, clinical validity, or safety, helping with FDA’s postmarket oversight for these IVDs. For example, as part of its review of labeling for currently marketed IVDs offered as LDTs, FDA intends to look closely at claims of superior performance and whether those claims are adequately substantiated. FDA generally intends to take action where the labeling of an IVD offered as a LDT is false or misleading, and/or the IVD offered as an LDT lacks the appropriate assurance of safety and effectiveness for its intended uses as a result of any such claims that are not adequately substantiated.
A: As described in the preamble to the final rule, FDA expects compliance with labeling requirements for most IVDs offered as LDTs by May 6, 2026. Labeling may include promotional material. The term ”labeling” is defined in the Federal Food, Drug, and Cosmetic Act as including “all labels and other written, printed, or graphic matter upon any article or any of its containers or wrappers, or accompanying such article.” Such materials must comply with labeling requirements, including the requirement to be truthful and non-misleading. Labeling that is not truthful or that is misleading would result in the product being misbranded.
As part of its labeling review, FDA also intends to look closely at claims of superior performance and whether such claims are adequately substantiated. Such claims are of particular public health concern because, in FDA’s experience, they have led to escalating claims from competitors that can ultimately mislead the public. FDA generally intends to take action where labeling, including promotional materials, for an IVD are false or misleading or where the test lacks appropriate assurance of safety and effectiveness for its intended uses as a result of any claims that are not adequately substantiated.
As described in the preamble to the final rule, FDA generally does not expect compliance with applicable requirements, including labeling requirements, for IVDs offered as LDTs under certain enforcement discretion policies, including 1976-Type LDTs, HLA tests for transplantation, forensic tests, and LDTs manufactured and performed within DoD and VHA.
A: As described in the preamble to the final rule, FDA expects compliance with labeling requirements for most IVDs offered as LDTs by May 6, 2026.
The IVD labeling requirements set forth in 21 CFR 809.10(b) specify the information that must be included in labeling accompanying each product, such as a package insert. However, the regulations do not require that the labeling be in the form of a package insert. As described in the preamble to the final rule, FDA anticipates that, for LDTs, the information required under 21 CFR 809.10(b) might be encompassed in more than one document, such as the test protocol, test report template, and test menu. In FDA’s experience to date, most laboratory manufacturers have met the requirements of 809.10(b) by maintaining a document summarizing the information required under 809.10(b), and additional documents that contain more detail, such as the test protocol, test report template, and test menu, which may include proprietary information. In these situations, FDA refers to the summary as the primary labeling document. For PMAs, FDA makes the primary labeling document publicly available on our website, whereas other detailed documents referenced in the primary labeling document, such as the test protocol, would be maintained confidentially.
Manufacturers are responsible for having compliant labeling and maintaining it on file regardless of whether it is submitted to FDA. For IVDs subject to premarket review, proposed labeling is generally required to be submitted as part of a premarket submission.
As described in the preamble to the final rule, for IVDs that fall within certain targeted enforcement discretion policies for which FDA intends to exercise enforcement discretion with respect to premarket review (specifically the targeted enforcement discretion policies for LDTs approved by the New York State Clinical Laboratory Evaluation Program (NYS CLEP), certain LDTs for unmet needs, and “currently marketed IVDs offered as LDTs” (i.e., those that were first marketed prior to May 6, 2024)), FDA intends to request that manufacturers submit labeling information to the Agency in connection with the listing of the IVD as provided in 21 CFR 807.26(e). FDA intends to provide further instructions regarding the submission of such labeling information at a later date.
A: Reagent and instrument specific labeling requirements can be found in 21 CFR 809.10(b)(5) and 21 CFR 809.10(b)(6), respectively. These requirements must be met for any test system for clinical diagnostic use that uses reagents and/or instruments.
Test systems often use reagents and instruments that are labeled for clinical diagnostic use. Some test systems, including LDTs, that use such reagents and instruments in accordance with their labeled intended use reference the compliant reagent and instrument labeling, rather than repeating the reagent and instrument labeling information in the test system labeling. These reagents and instruments are typically listed in the test system labeling as the materials that are “required but not provided”, as required under 809.10(b)(8)(ii).
In contrast, in some cases, test systems use reagent(s) or instrument(s) that are NOT appropriately labeled for clinical diagnostic use (such as reagents and instruments intended for research use only) or where the reagents and instruments are being used in the test system in a manner that is not in accordance with their labeled intended use. As discussed in the preamble to the LDT final rule, if a laboratory chooses to use one or more RUO components in its IVDs offered as LDTs, then the laboratory is responsible for qualifying such components in its IVDs under their own quality system. As such, the laboratory manufacturer is responsible for complying with the applicable labeling requirements, such as including information in the test system labeling to meet the requirements of 809.10(b)(5) and 809.10(b)(6). As discussed for other aspects of labeling, for LDTs, FDA anticipates that this information may be contained in more than one document, such as summary information in a primary labeling document and additional details in other documents such as a test protocol or reagent and instrument qualification documentation.
A: 21 CFR 809.10(b)(12) requires labeling to include information on the specific performance characteristics for the test system. This must include, as appropriate, information describing such things as accuracy, precision, specificity, and sensitivity. These must be related to a generally accepted method using biological specimens from normal and abnormal populations. A statement summarizing the data upon which the specific performance characteristics are based must be included.
The specific performance characteristics required to be included in the labeling may include performance characteristics beyond accuracy, precision, sensitivity and specificity, depending on which performance characteristics are relevant for demonstrating the test system’s safety and effectiveness. For example, linearity performance is relevant for quantitative test systems. Performance characteristics typically include both analytical and clinical performance.
While labeling for a test system must include a summary of the data, additional details of the validation are generally expected in a premarket submission.
A: The intended use of a device is the general purpose of the device or its function and includes its indications for use. The indications for use is the disease or condition the device will diagnose, treat, prevent, cure, or mitigate, including a description of the patient population for which the device is intended. The intended use of an IVD drives its classification (as discussed in the IVD Classification Webinar) and may impact the eligibility of the LDT for most enforcement discretion policies described in the preamble to the LDT Final Rule.
For every IVD, including IVDs offered as LDTs, for which FDA intends to enforce compliance with labeling requirements (generally all IVDs described in the final rule except public health surveillance tests, 1976-Type LDTs, forensic tests and LDTs manufactured and performed within DoD and VHA as described in Section V.B.1 of preamble), labeling should include a clear intended use statement, including an indication for use. An Intended Use statement is a required element of IVD Labeling under 21 CFR 809.10.