Phaseout Policy and Enforcement Discretion Policies: Laboratory Developed Tests FAQs
General
A: FDA is phasing out its general enforcement discretion approach to help assure the safety and effectiveness of IVDs offered as LDTs. As discussed in the preamble to the final rule, FDA recognizes the role that laboratory-manufactured tests play in modern healthcare, the effect that the Agency's longstanding enforcement discretion approach for LDTs has had on the market, and the presence of other expert regulatory bodies. FDA's phaseout of the general enforcement discretion approach and targeted enforcement discretion policies balance the important public health considerations at issue (for a comprehensive discussion of those considerations, please refer to section III.B of the preamble to the final rule, as well as the discussions of the various enforcement discretion policies throughout the preamble to the rule).
As discussed in the preamble to the final rule, for example, we included an enforcement discretion policy for currently marketed IVDs offered as LDTs in consideration of concerns that expecting compliance with full quality system and premarket review requirements for such IVDs could lead to the loss of access to safe and effective IVDs on which patients currently rely. We also included an enforcement discretion policy for LDTs manufactured and performed by a laboratory integrated within a healthcare system to meet an unmet need of patients receiving care within the same healthcare system in consideration of concerns that expecting full compliance with FDA requirements could lead to loss of access to such LDTs for which laboratories cannot recoup the costs of compliance. FDA has also adopted enforcement discretion policies that recognize the regulatory role that certain other Federal and State entities play.
A: As described in the preamble to the final rule, for IVDs offered as LDTs that were marketed on the date of issuance of the rule, the FDA generally intends to exercise enforcement discretion with respect to premarket review and QS requirements (except for requirements under 21 CFR part 820, subpart M (Records)), as long as they are not modified following the issuance of this final rule, or are modified but only in a limited way. As noted in the preamble to the final rule, this enforcement discretion policy applies only to premarket review and most QS requirements.
For other types of IVDs, please refer to the preamble to the final rule to determine whether another enforcement discretion policy applies to your IVD.
A: The specified timelines for the phaseout policy stages are set for 1-4 years after the publication date of May 6, 2024.
A: The FDA notes that its premarket review timelines are negotiated with industry in connection with MDUFA reauthorization. FDA generally meets the timeframes for MDUFA decisions negotiated with industry, including for IVD submissions outside of the pandemic. As previously mentioned, reauthorization of MDUFA aligns with the timeline for industry to come into compliance with premarket review requirements under the phaseout policy. This will provide an opportunity for FDA and industry to negotiate regarding user fees and performance goals for premarket reviews.
A: The issuance date of the final rule is May 6, 2024. Some IVDs manufactured and first offered by laboratories after the date of issuance of the final rule may fall within a targeted enforcement discretion policy described in the preamble. We have posted a table on our website to help manufacturers better understand the general expectations of IVDs falling within these policies, but refer you to the preamble for complete details.
The phaseout policy details when compliance with different requirements is expected. As discussed during the presentation,
- Beginning May 6, 2025, FDA will expect compliance with MDR requirements for correction and removal reporting requirements and complaint files.
- Beginning May 6, 2026, FDA will expect compliance with requirements not covered during other stages of the phaseout policy, including registration and listing, labeling requirements, and investigational use requirements.
- Beginning May 6, 2027, FDA will expect compliance with quality system requirements not included in earlier stages. Note that for LDTs specifically, FDA expects compliance with the following elements of the QS regulations: design controls, purchasing controls, acceptance activities, CAPA, and records requirements.
- Beginning November 6, 2027, 3.5 years after the publication date of this final rule, FDA will expect compliance with premarket review requirements for high-risk devices IVDs offered as LDTs.
- Beginning May 6, 2028, 4 years after the publication date of this final rule, FDA will expect compliance with premarket review requirements for moderate-risk and low-risk IVDs offered as LDTs that require premarket review. Note that most low risk IVDs are exempt from premarket review.
FDA generally does not intend to enforce premarket review requirements after a complete PMA, 510(k), or De Novo request has been submitted until FDA completes its review of the submission where the PMA, 510(k), or De Novo request has been submitted within the applicable 3.5 or 4-year timeframe as detailed in the phaseout policy. Given that such IVDs may already be on the market and available to patients, FDA generally does not intend to interrupt access at the point when a submission is made. IVDs for which a PMA, 510(k), or De Novo request is submitted after the applicable timeframe detailed in the phaseout policy would not fall within this enforcement discretion policy; FDA approval, clearance or authorization is expected prior to such IVDs being offered.
A: In general, IVDs cannot be offered for clinical use before FDA authorization, if authorization is required based on the classification of the IVD. There are certain limited exceptions (for example, investigational use or compassionate use).
On May 6, 2024, FDA published the LDT Final Rule. The preamble to the LDT Final Rule describes several targeted enforcement discretion policies applicable to specific types of IVDs manufactured by a laboratory, pursuant to which FDA generally intends not to enforce some or all applicable requirements. We have posted a table on our website to help manufacturers better understand FDA's general expectations for IVDs falling within these policies, but refer you to the preamble for complete details.
Generally, for IVDs offered as LDTs that do not fall within a targeted enforcement discretion policy described in the preamble, compliance with premarket review requirements is expected starting with Stage 4, beginning on November 6, 2027, for high risk IVDs offered as LDTsand Stage 5, beginning on May 6, 2028, for moderate risk and low risk IVDs offered as LDTs (that require premarket submission), unless a premarket submission has been received by the beginning of this stage in which case FDA intends to continue to exercise enforcement discretion for the pendency of its review.
A: If a laboratory manufacturer submits a premarket submission that is ultimately not successful, they should discuss their plans for how to address the results previously provided to patients with the review division that conducted the premarket review for that test.
A: As referenced throughout the preamble to the LDT final rule, an IVD is considered an LDT if the IVD is intended for clinical use and is designed, manufactured, and used within a single laboratory that is certified under CLIA and meets the regulatory requirements under CLIA to perform high complexity testing. This includes a laboratory’s modified version of an FDA-authorized or 510(k)-exempt IVD that meets that description.
1976-Type Tests
A: In general, "1976-Type LDTs" have the following characteristics :
- use of manual techniques (without automation) performed by laboratory personnel with specialized expertise;
- use of components legally marketed for clinical use; and
- design, manufacture, and use within a single CLIA-certified laboratory that meets the requirements under CLIA for high complexity testing.
Tests with these three characteristics generally fall within FDA's "1976-Type LDT" enforcement discretion policy. Fluorescence in situ hybridization on cytogenetic cell preparations and IHC tests often have these three characteristics and thus would fall within the enforcement discretion policy for 1976-type LDTs.
Tests using automation, including automated staining methods, automated plate readers, or automated interpretation, would not have this first characteristic because they do not use manual techniques without automation.
A test with components labeled "research use only" (RUO) would not have the second characteristic because appropriately labeled research use only IVD products are not legally marketed for clinical use.
Currently marketed IVDs offered as LDTs
A: First, the rule does not "grandfather" any IVDs. If an IVD was offered as an LDT prior to 5/6/2024 and is not modified in such a way that changes the indications for use, alters the operating principle, includes significantly different technology, or adversely changes the performance or safety specifications of the IVD, FDA intends to exercise enforcement discretion and generally not enforce premarket review and QS requirements (except for requirements under part 820, subpart M (Records)). This policy is not limited to manual tests.
Additionally, for tests that have certain characteristics common among LDTs offered in 1976, FDA intends to exercise enforcement discretion and generally not enforce applicable requirements. The characteristics of tests under this policy are:
- use of manual techniques (without automation) performed by laboratory personnel with specialized expertise;
- use of components legally marketed for clinical use; and
- design, manufacture, and use within a single CLIA-certified laboratory that meets the requirements under CLIA for high complexity testing.
The enforcement discretion policies for 1976-type tests and "currently marketed IVDs offered as LDTs" (i.e., those that were first marketed prior to May 6, 2024) are separate, although some tests may fall under both.
Note that certain donor screening tests, tests intended for emergencies, potential emergencies, or material threats declared under section 564, and DTC tests are excluded from the scope of the phaseout policy. FDA continues to expect compliance with applicable requirements for such tests, regardless of whether they would otherwise fall within an enforcement discretion policy described in the preamble.
Modifications
As described in the preamble to the final rule, FDA intends to exercise enforcement discretion and generally not enforce premarket review and QS requirements for modifications to currently marketed IVDs offered as LDTs first marketed prior to the date of issuance of the rule that do not (individually or in aggregate):
- change the indications for use of the IVD;
- alter the operating principle of the IVD (for example, changes in critical reaction components);
- include significantly different technology in the IVD (e.g., addition of artificial intelligence or machine learning to the test algorithm, a change from targeted sequencing to whole genome sequencing, a change from immunoassay to mass spectrometry, or a change from manual to automated procedures); or
- adversely change the performance or safety specifications of the IVD.
A: As described in the preamble to the final rule, FDA generally does not intend to enforce premarket review requirements for certain laboratory changes to another manufacturer's lawfully marketed test. This policy applies when a CLIA-certified laboratory that meets CLIA requirements to perform high complexity testing modifies another manufacturer's test 510(k) cleared or De Novo authorized test (i) following design controls and other quality system requirements for which FDA expects compliance, (ii) in a manner that could not significantly affect the safety or effectiveness of the test and does not constitute a major change or modification in intended use, and (iii) where the modified test is performed only in the laboratory making the modification. FDA expects premarket submissions from laboratories modifying a third party's cleared or authorized test for the same types of changes for which FDA would expect a premarket submission from the original manufacturer modifying its own test.
FDA is adopting this policy to promote more efficient and effective use of Agency resources and because it understands laboratories may make such changes to, for example, integrate a test into its operations, accommodate local conditions (e.g., storage conditions), or address supply shortages. Taking into account the risks associated with relatively minor changes to 510(k) cleared or De Novo authorized tests when they occur in a single laboratory (i.e., without broad distribution), at this time, we believe the resources needed to review these types of changes generally can be better spent on other Agency priorities and activities. We are not applying this enforcement discretion policy to modifications to another manufacturer's PMA-approved or BLA-licensed test because such tests are high-risk, and changes to such tests pose corresponding increased risks. We note that relatively few IVDs are considered high risk today, and, further, FDA has announced its intent to initiate the reclassification process for most IVDs that are currently class III into class II. We therefore anticipate that there will be even fewer class III (high-risk) IVDs going forward. As such, these tests present resource considerations that are different from those discussed above.
A: As discussed in the phaseout policy, FDA generally does not expect compliance with premarket review and most QS requirements for "currently marketed IVDs offered as LDTs" (i.e., those that were first marketed prior to May 6, 2024) as long as they are not modified following issuance of the final rule, or are modified but only in certain limited ways. FDA generally expects compliance with premarket review and QS requirements for currently marketed IVDs offered as LDTs when modifications are made that change the indications for use of the IVD, alter the operating principle of the IVD, include significantly different technology in the IVD, or adversely change the performance or safety specifications of the IVD. For example, where a laboratory does routine instrument replacement, the IVD offered as an LDT may continue to fall within the enforcement discretion policy for currently marketed IVDs offered as LDTs if the modified test is not within any of those circumstances.
A: FDA's regulatory requirements for modifications to cleared or approved devices including IVDs apply to IVDs offered as LDTs. The guidance documents, "Deciding When to Submit a 510(k) for a Change to an Existing Device - Guidance for Industry and Food and Drug Administration Staff" and "Modifications to Devices Subject to Premarket Approval (PMA) - The PMA Supplement Decision-Making Process Guidance for Industry and FDA Staff" are good resources for understanding regulatory requirements related to pre-market submissions for modified devices.
In addition, as described in the preamble to the LDT Final Rule, there are targeted enforcement discretion policies which may apply to certain modified IVDs.
Specifically, as discussed in the phaseout policy described in the preamble to the LDT Final Rule, FDA generally does not expect compliance with premarket review and most QS requirements for "currently marketed IVDs offered as LDTs" (i.e., those that were first marketed prior to May 6, 2024) as long as they are not modified following issuance of the final rule, or are modified but only in certain limited ways. FDA generally expects compliance with premarket review and QS requirements for currently marketed IVDs offered as LDTs when modifications are made that change the indications for use of the IVD, alter the operating principle of the IVD, include significantly different technology in the IVD, or adversely change the performance or safety specifications of the IVD.
Additionally, as described in the preamble to the final rule, FDA generally does not intend to enforce premarket review requirements for certain laboratory changes to another manufacturer's lawfully marketed test. This policy applies when a CLIA-certified laboratory that meets CLIA requirements to perform high complexity testing modifies another manufacturer's test 510(k) cleared or De Novo authorized test (i) following design controls and other quality system requirements for which FDA expects compliance, (ii) in a manner that could not significantly affect the safety or effectiveness of the test and does not constitute a major change or modification in intended use, and (iii) where the modified test is performed only in the laboratory making the modification. FDA expects premarket submissions from laboratories modifying a third party's cleared or authorized test for the same types of changes for which FDA would expect a premarket submission from the original manufacturer modifying its own test.
A: When a laboratory modifies another manufacturer’s FDA-authorized IVD, the laboratory must comply with applicable premarket review requirements, which may involve submitting a premarket notification as set forth in 21 CFR 807.81(a)(2), a de novo request for authorization as set forth in 21 CFR 860.200(b), or a premarket approval application as set forth in 21 CFR 814.1(c), unless the modified IVD is exempt from premarket notification requirements. This IVD would be considered an LDT if the IVD is intended for clinical use and is designed, manufactured, and used within a single laboratory that is certified under CLIA and meets the regulatory requirements under CLIA to perform high complexity testing. For example, if a laboratory modifies another manufacturer’s FDA-authorized IVD by updating its labeling to be for use in pediatrics, where the original IVD was cleared for use in adults only, the laboratory would need to comply with applicable premarket review requirements for that IVD. The laboratory/IVD also would be required to meet other applicable requirements. Notably, the manufacturer of the original IVD would not be responsible for compliance with device requirements for the modified IVD, although that manufacturer may choose to consult with and assist the laboratory with compliance.
We also note that the preamble to the LDT final rule includes several targeted enforcement discretion policies for certain device requirements for certain IVDs offered as LDTs, including a policy for premarket review requirements for certain IVDs that are laboratory modified versions of another manufacturer’s 510(k)-cleared or De Novo-authorized test. Please see sections V.C.4 and V.C.5 of the preamble for additional information.
NYS CLEP Tests
A: For LDTs approved, conditionally approved, or within an approved exemption from full technical documentation by NYS CLEP (collectively referred to as LDTs approved by NYS CLEP), FDA intends to exercise enforcement discretion and generally not enforce premarket review requirements. As described in the preamble, this enforcement discretion policy for premarket review requirements only applies to the version of the LDT approved by NYS CLEP. Therefore, if a test is not approved by NYS CLEP, it would not fall within this enforcement discretion policy.
A: No, we intend to exercise enforcement discretion only for premarket review for LDTs approved by, conditionally approved by, or within an approved exemption from full technical documentation under NYS CLEP. For all other applicable requirements, including for example MDR, corrections and removals, labeling, and quality systems, FDA intends to phaseout the general enforcement discretion approach consistent with the stages described in the preamble to the final rule.
A: For currently marketed IVDs offered as LDTs, i.e., those that were marketed prior to May 6, 2024, FDA intends to exercise enforcement discretion and generally not enforce premarket review and QS requirements (except for requirements under part 820, subpart M (Records)) provided they are not modified or are modified only in certain limited ways.
For new IVDs offered as LDTs, i.e., those not marketed prior to May 6, 2024, FDA expects compliance with applicable premarket review, QS, and other device requirements, consistent with the stages described in the preamble to the final rule. However, if such new IVD falls within an enforcement discretion policy described in the preamble to the final rule, FDA intends to exercise enforcement discretion as described in the applicable policy.
One of the enforcement discretion policies described in the preamble to the final rule relates to LDTs that are approved, conditionally approved, or within an approved exemption from full technical documentation under NYS CLEP. For such LDTs, FDA intends to exercise enforcement discretion and generally not enforce premarket review requirements.
A: FDA intends to enforce premarket review requirements for moderate-risk and low-risk IVDs offered as LDTs (that require premarket submissions) beginning in May 2028. However, FDA generally intends to exercise enforcement discretion with respect to premarket review requirements for LDTs approved by NYS CLEP, including LDTs approved by NYS CLEP prior to May 2028. See the preamble to the final rule for further information (88 FR 37286).
A: As described in the preamble to the final rule, FDA generally intends to exercise enforcement discretion with respect to premarket review requirements for LDTs that are approved by NYS CLEP. This policy applies only to the approved version of the test. For purposes of this policy, FDA uses the phrase “LDTs approved by NYS CLEP” to refer to LDTs that are approved, conditionally approved, or within an approved exemption from full technical documentation, under NYS CLEP.
If a laboratory submits a modification to NYS CLEP and obtains approval for the modified version of their LDT from NYS CLEP, the modified version of the LDT may fall within this enforcement discretion policy.
A: For LDTs receiving conditional approval by NYS CLEP, full technical review is pending, and these tests may receive approval by NYS CLEP once their review has been completed. As described in the preamble, FDA does not intend to use its resources to enforce premarket review requirements for these LDTs that are under review by NYS CLEP and may eventually receive approval. However, if an LDT has its conditional approval withdrawn by NYS (e.g., because approval is denied after NYS CLEP completes the full technical review), the LDT would no longer be under this enforcement discretion policy as it would have neither conditional approval nor full approval (nor be within an approved exemption from full technical documentation) under NYS CLEP.
A: FDA intends to exercise enforcement discretion and generally not enforce premarket review and most Quality System (QS) requirements, including design controls, for currently marketed IVDs offered as LDTs that were first marketed prior to the rule publication date (May 6, 2024), whether or not such tests have been approved by NYS CLEP. For IVDs offered as LDTs that are first marketed on or after May 6, 2024, including LDTs approved by NYS CLEP, FDA expects compliance with QS requirements, including design controls, by Stage 3 of the phaseout policy (May 6, 2027), unless the IVD falls within an enforcement discretion policy under which FDA generally does not intend to enforce QS requirements. For LDTs (i.e., IVDs that are intended for clinical use and that are designed, manufactured, and used within a single CLIA-certified laboratory that meets the regulatory requirements under CLIA to perform high complexity testing), the QS requirements for which FDA expects compliance by Stage 3 of the phaseout policy are: design controls, purchasing controls, acceptance activities, CAPA (corrective and preventive actions), and records requirements.
A: The enforcement discretion policy with respect to LDTs approved by NYS CLEP applies regardless of whether that LDT is performed on specimens from NYS or elsewhere, as the risk mitigations upon which the policy is based apply regardless of where the specimens are coming from. This policy applies only to the approved version of the test (FDA is aware that some laboratories may offer different versions of an LDT depending on whether a patient specimen comes from NYS or from elsewhere).
A: As explained in the preamble to the final rule, FDA uses the phrase “LDTs approved by NYS CLEP” to refer to LDTs that are approved, conditionally approved, or within an approved exemption from full technical documentation, under NYS CLEP. FDA generally intends to exercise enforcement discretion with respect to premarket review requirements for LDTs that are approved by NYS CLEP, including LDTs that use one or more RUO components. For LDTs that are approved by NYS CLEP, FDA expects compliance with other requirements, including Quality System (QS) requirements for design controls, purchasing controls, acceptance activities, CAPA (corrective and preventive actions) and records requirements, as described in the phaseout policy. The laboratory is expected to manage the quality of components, including RUO components, under their quality system.
A: FDA generally intends to exercise enforcement discretion with respect to premarket review requirements for LDTs that are approved by NYS CLEP, including LDTs approved by NYS CLEP after Stages 4 or 5 of the phaseout policy.
Rare Diseases/Unmet Needs
As described in the preamble to the final rule, the FDA considers an LDT to be for an unmet need where there is no available FDA-authorized IVD that meets the patient's needs. This may be because: (1) there is no FDA-authorized IVD for the disease or condition (for example, because it is for a rare disease or condition); (2) there is an FDA-authorized IVD for the disease or condition but it is not indicated for use on the patient, or a unique attribute needs to be added to the LDT to meet the patient's needs; or (3) there is an FDA-authorized IVD but it is not available to the patient. Examples of LDTs for unmet needs are:
- An LDT that is intended for cytogenetic analysis of certain genes and chromosomes associated with rare diseases or conditions, certain metals testing, viral load monitoring for some transplant-associated viruses, or diagnosis of certain mosquito- and tick-borne-diseases, where there is no FDA-authorized IVD for the disease/condition (rare disease or condition);
- An LDT to accommodate an alternative specimen type that is infrequently tested when the specimen type required for the FDA-authorized IVD is not and cannot be made available (variation from the indications for use of an FDA-authorized IVD);
- An LDT for use on pediatric patients when FDA-authorized IVDs are indicated for use on adults only (variation from the indications for use of an FDA-authorized IVD);
- An LDT that generates results in a significantly shorter period (e.g., hours versus days) than an FDA-authorized IVD with the same indication where, due to the circumstances of the patient, the shorter time period to get results is critical for the clinical decision being made (unique attribute needed to be added to an FDA-authorized IVD);
- An LDT for the same indication as an FDA-authorized IVD that is offered only in another healthcare system that is not accessible to the patient and the developing laboratory will not make the IVD available outside its system (FDA-authorized IVD is not available); and
- An LDT for an emerging pathogen for which there is no FDA-authorized IVD and for which FDA has not identified an emergent situation (no FDA-authorized IVD).
In contrast, as described in the preamble to the final rule, the FDA does not consider an LDT to be for an unmet need when there is an available FDA-authorized IVD that would sufficiently meet the needs of the patient. For example, potential improvements in performance or lower cost in comparison to an FDA-authorized IVD that meets the patient's needs does not fall within this policy.
A: FDA recognizes the challenges faced by patients with rare diseases, their families, and their treating physicians. FDA also recognizes that IVDs offered as LDTs play an important role in healthcare and may address various unmet needs including for rare diseases. We believe several of the enforcement discretion policies adopted in the phaseout policy will help to address the availability of IVDs for unmet needs and rare diseases. For example, FDA intends to exercise enforcement discretion and generally not enforce premarket review and QS requirements (except for requirements under part 820, subpart M (Records)) for "currently marketed IVDs offered as LDTs" (i.e., those that were first marketed prior to May 6, 2024) that are not modified or that are modified in certain limited ways. In addition, FDA intends to exercise enforcement discretion and generally not enforce premarket review and QS requirements (except for requirements under part 820, subpart M (Records)) for LDTs manufactured and performed by a laboratory integrated within a healthcare system to meet an unmet need of patients receiving care within the same healthcare system. This policy is intended, among other things, to address situations where there is no available FDA-authorized IVD for the disease or condition, which may be the case for rare diseases or smaller patient populations. [Note that this policy is not limited to IVDs offered to 8k patients or less per year in the US, which is the statutory threshold for Humanitarian Use Devices.]
FDA recognizes it can be challenging to validate tests for rare diseases or smaller patient populations where it is difficult to obtain clinical samples. FDA intends to consider whether issuing additional guidance regarding validation of tests, including those for rare diseases that takes into consideration the challenges in obtaining a robust number of samples for validation, would be helpful.
A: As discussed in the preamble to the final rule, FDA did not adopt an enforcement discretion policy for LDTs for rare diseases. We note that under the FD&C Act, the threshold for Humanitarian Use Designation for an IVD is that it is offered to no more than 8k patients across the US per year.
However, the phaseout policy includes an enforcement discretion policy for certain LDTs for unmet needs, which may include LDTs for rare diseases. As described in the preamble to the final rule, FDA intends to exercise enforcement discretion and generally not enforce premarket review requirements and QS requirements (except for requirements under part 820, Subpart M) for LDTs manufactured and performed by a lab integrated within a healthcare system to meet an unmet need of patients receiving care within that same healthcare system. FDA considers an LDT to be for an unmet need where there is no available FDA-authorized IVD that meets the patient's need, which may include circumstances where there is no FDA-authorized IVD for a rare disease or condition. FDA intends this policy to be targeted. It is not intended to serve as an alternative "pathway" to market for LDTs for unmet needs. FDA intends to provide additional guidance on this enforcement discretion policy.
A: If there is no longer an unmet need for an LDT because, for example, FDA authorizes an IVD that meets the needs of the patient, then the LDT would no longer fall within this enforcement discretion policy. However, if a new IVD receives FDA authorization for the same indication as an LDT offered as described in this enforcement discretion policy, but is offered in another healthcare system that is not accessible to the patient and the laboratory manufacturing the new IVD does not make it available outside its system, for example, then the FDA-authorized IVD would not be available to the patient, and the LDT would continue to be an LDT for an unmet need.
Forensic Tests
A: For tests intended solely for forensic (law enforcement) purposes, FDA intends to exercise enforcement discretion and generally not enforce any applicable requirements. FDA has had an enforcement discretion approach for these tests for over 20 years and has applied this approach regardless of whether the tests are offered as an LDT. Tests used in law enforcement are subject to protections and requirements that mitigate risk related to test accuracy and sample collection. An LDT that is used for forensic and other purposes does not fall within this policy, though it may fall within another enforcement discretion policy in the phaseout policy.