Definitions and General Oversight: Laboratory Developed Tests FAQs
General
A: In general, FDA regulatory requirements are not impacted by the frequency or volume a test is used. However, we note that devices that are designed to treat or diagnose a disease or condition that affects not more than 8,000 individuals in the United States on an annual basis may be eligible for a different type of pre-market submission, called a humanitarian device exemption. In the case of devices used for diagnostic purposes, humanitarian device exemptions are limited to devices for which not more than 8,000 individuals per year would be subject to diagnosis by the device in the United States. You may find more information on the HDE program, including a link to the HDE guidance, on FDA's HDE webpage.
For IVDs offered as LDTs, please refer to the preamble to the LDT final rule and FDA's Laboratory Developed Tests website for additional information regarding applicable requirements and FDA's policy for phasing out the general enforcement discretion approach for LDTs.
A: As discussed during the webinar presentation "FDA's Total Product Lifecycle Approach to IVDs", the analytical and clinical validation for each submission may depend on a number of factors, including the analyte detected, the technology used to measure it, the specific claims made by the manufacturer and the risks of wrong results. To understand the type of validation information FDA may expect to review, FDA encourages the use of the resources in the presentation such as recognized consensus standards, including many CLSI guidelines (the searchable database for FDA recognized consensus standards can be found at Recognized Consensus Standards: Medical Devices, as well as decision summaries that show the type of information that FDA has previously found appropriate to support a 510(k), PMA, or De Novo submission for similar test systems. FDA also issues a number of guidance documents that may be helpful in gathering data and preparing for a premarket submission, which can be found on our website as well. These can be located at Guidance Documents (Medical Devices and Radiation-Emitting Products). When manufacturers have specific questions that are not addressed by any of the publicly available resources, they may submit a pre-submission, as described in the FDA guidance "Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program."
A: When a laboratory modifies another manufacturer’s IVD, for example, by changing the intended use or the operating principles of the IVD, the laboratory has manufactured a new IVD and is the manufacturer of that IVD.
A: In general, statements made by a manufacturer that promote an FDA-approved/cleared IVD for a use outside of its approval/clearance may be used as evidence of a new intended use (see 21 CFR 801.4). Offering an IVD for a new intended use without FDA approval or clearance, as applicable, would generally violate the Federal Food, Drug, and Cosmetic Act. However, FDA has long taken the position that a manufacturer can respond to unsolicited requests for information about an “approved or cleared product” by providing truthful, balanced, non-misleading, and nonpromotional scientific or medical information that is responsive to the specific request, even if responding to the request requires the manufacturer to provide information on unapproved or uncleared indications or conditions of use (see footnote 2 of the draft guidance (Guidance for Industry: Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices) regarding the scope of “approved or cleared product”). If responses to unsolicited requests fall within these parameters, FDA has not considered the responses as evidence of intended use. Please see the draft guidance (Guidance for Industry: Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices) for additional information.
A: No. Under section 1006 of the FD&C Act, “[n]othing in this Act shall be construed to limit or interfere with the authority of a healthcare provider to prescribe or administer any legally marketed device to a patient for any condition or disease within a legitimate health care practitioner-patient relationship.”
A: FDA generally would consider there to be “meaningful involvement by a licensed healthcare professional” when the professionals “help determine whether a particular test [is] appropriate, counsel patients on the significance and limitations of a test, assist in interpreting results, assess how the results fit in the overall clinical picture, and consider next steps.” 89 FR at 37296. In the absence of such involvement, the risks to patients are greater, and there is greater need for FDA oversight.
Q: How are research use only (RUO) and investigational use only (IUO) products impacted by the rule?
A: The rule does not change FDA’s final guidance document that addresses RUO and IUO IVDs (see Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only). As discussed in that guidance, both RUO and IUO IVDs are currently under development and not approved or cleared for clinical diagnostic use. The term RUO refers to devices that are in the laboratory phase of development. The term IUO refers to devices that are in the product testing phase of development. The guidance states that “RUO and IUO labeling must be consistent with the manufacturer’s intended use of the device.”
If a laboratory chooses to use one or more RUO or IUO components or other components not legally marketed for clinical use in its IVDs offered as LDTs, then the laboratory is responsible for qualifying such components in its IVDs. For those IVDs offered as LDTs for which the phaseout policy with respect to the QS requirements would apply, as long as the laboratory has implemented a quality system that meets the QS requirements, as applicable, and is able to appropriately manage the quality of these components under that quality system, then the components may be incorporated as part of an IVD offered as an LDT (see section V.C.3 of the preamble to the LDT final rule for a discussion of when FDA generally expects compliance with the QS requirements for IVDs offered as LDTs). The component(s) will be reviewed in the premarket submission for the IVD offered as an LDT, if applicable.
The IDE requirements under section 520(g) of the FD&C Act and 21 CFR Part 812 apply to clinical investigations of devices. Certain investigational IVD device studies, however, are exempt from most of the provisions of 21 CFR Part 812 (21 CFR 812.2(c)(3)). FDA has several resources available to help sponsors and investigators comply with IDE requirements in the context of clinical investigations of IVDs, including the final guidance entitled In Vitro Diagnostic (IVD) Device Studies - Frequently Asked Questions.
A laboratory that is a sponsor of, and an investigator who conducts, a clinical investigation of an IVD (including one that may include reagents or instruments that were previously labeled RUO or IUO by a third-party manufacturer) is responsible for ensuring compliance with all applicable requirements under the FD&C Act and FDA’s regulations. Under the phaseout policy described in the preamble to the final rule, FDA expects compliance with applicable IDE requirements and associated requirements, including requirements found in 21 CFR Parts 50 and 56 of FDA’s regulations, for investigations that involve investigational IVDs offered as LDTs beginning on May 6, 2026, which is 2 years after publication of the final rule.
A: If a laboratory chooses to use one or more RUO or IUO components or other components not legally marketed for clinical use in its IVDs offered as LDTs, then the laboratory is responsible for qualifying such components in its IVDs. For those IVDs offered as LDTs for which the phaseout policy with respect to the QS requirements would apply, as long as the laboratory has implemented a quality system that meets the QS requirements, as applicable, and is able to appropriately manage the quality of these components under that quality system, then the components may be incorporated as part of an IVD offered as an LDT (see section V.C.3 of the preamble to the LDT final rule for a discussion of when FDA generally expects compliance with the QS requirements for IVDs offered as LDTs). The component(s) will be reviewed in the premarket submission for the IVD offered as an LDT, if applicable.
Additionally, FDA has issued a final guidance document that addresses RUO and IUO IVDs (see Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only). As explained in the final guidance, the RUO or IUO labeling is meant to serve as a warning to prevent such products from being used in clinical diagnosis, patient management, or an investigation that is not exempt from FDA’s regulations under 21 CFR part 812. In general, IVDs that are intended for clinical diagnosis or patient management must be labeled “For In Vitro Diagnostic Use” (see 21 CFR § 809.10(a)(4)) and be in compliance with all applicable requirements for in vitro diagnostic devices. As noted in the guidance, if an IVD is intended for clinical diagnostic use, it should not be labeled RUO or IUO. Also as discussed in the guidance, if an IVD intended for clinical diagnostic use were labeled as RUO or IUO, FDA would consider such an IVD to be misbranded, because such labeling would be false or misleading.
A: The LDT final rule does not change the legal requirements for manufacturers of RUO-labeled or IUO-labeled devices that are being used by another entity as part of an IVD offered as an LDT, nor does the rule change the legal requirement that “RUO and IUO labeling must be consistent with the manufacturer’s intended use of the device” as stated in FDA’s final guidance document that addresses RUO and IUO IVDs (see Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only). That guidance explains appropriate labeling and distribution practices for RUO and IUO IVDs, including examples of distribution practices that are inconsistent with RUO/IUO designations. The following are examples of evidence that may be evaluated when determining a manufacturer’s intended use: any written or verbal statements in any labeling, advertising, or promotion of the IVD product by or on behalf of the manufacturer, including any performance claims, instructions for clinical interpretation, or clinical information that claim or suggest that the IVD product may be used for any clinical diagnostic use; any written or verbal statements in any labeling, advertising, or promotion of the IVD product by the manufacturer that suggest that clinical laboratories can validate the test through their own procedures and subsequently offer it for clinical diagnostic use as an LDT; solicitation of business from clinical laboratories; or providing assistance to a clinical laboratory in performing clinical validation.
If a laboratory chooses to use one or more RUO or IUO components or other components not legally marketed for clinical use in its IVDs offered as LDTs, then the laboratory is responsible for qualifying such components in its IVDs. For those IVDs offered as LDTs for which the phaseout policy with respect to the QS requirements would apply, as long as the laboratory has implemented a quality system that meets the QS requirements, as applicable, and is able to appropriately manage the quality of these components under that quality system, then the components may be incorporated as part of an IVD offered as an LDT (see section V.C.3 of the preamble to the LDT final rule for a discussion of when FDA generally expects compliance with the QS requirements for IVDs offered as LDTs). The component(s) will be reviewed in the premarket submission for the IVD offered as an LDT, if applicable.
A: Manufacturers will use an FEI number (which may also be referred to as a firm establishment identifier number) when they register their establishment and list a device, submit a medical device report (MDR), or submit a correction or removal report. Manufacturers can request an FEI number before submitting an MDR or correction or removal report by contacting feiportal@fda.hhs.gov. Manufacturers will receive an FEI number, if they don't already have one, when they register their establishment.
A: You can request an FEI number by providing the following information to feiportal@fda.hhs.gov:
- The legal name of the firm being registered;
- Whether you are representing the firm as an Agent (third party);
- Any alternate firm names, including those used for "doing business as" purposes;
- The physical address of the firm being registered;
- The designated mailing address for the firm being registered;
- The name and contact information of the designated contact person at the facility being registered;
- A comprehensive list of activities conducted at this specific location (e.g., manufacturing of IVD offered as an LDT).
- Any registration numbers associated with other FDA Centers (if applicable);
- Any former names the firm was known by; and
- Any previous addresses linked to the firm.
For responses to frequently asked questions (FAQs) on requesting an FEI number, please see FEI Search Portal (fda.gov).
A: No, an FEI number is distinct from a CLIA number, and establishments that manufacture IVDs offered as LDTs will be designated an FEI number following standard FDA procedures. These procedures are not based on CLIA numbers. The registration and listing requirements applicable to IVDs offered as LDTs are the same as those applicable to other IVDs and other devices; FDA did not establish any new registration and listing requirements as part of the LDT rulemaking.
A: If your organization has determined that multiple laboratories each need an FEI number, you can submit the information for each laboratory all together in a spreadsheet.
What is an LDT?
A: Laboratory developed tests, or LDTs, are in vitro diagnostic products (IVDs) that are intended for clinical use and designed, manufactured, and used within a single clinical laboratory that is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and meets the regulatory requirements under CLIA to perform high complexity testing.
IVDs are devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act) including when the manufacturer of the IVD is a laboratory. IVDs are intended for use in the collection, preparation, and examination of specimens taken from the human body, such as blood, saliva, or tissue. IVDs, including LDTs, can be used to measure or detect substances or analytes in the body, such as proteins, glucose, cholesterol, or DNA, to provide information about a patient's health, including to diagnose, monitor, or determine treatment for diseases and conditions.
A: The final rule, including the phaseout policy described in the preamble to the final rule, is intended to better protect the public health by helping to assure the safety and effectiveness of IVDs offered as LDTs, while also accounting for other important public health considerations such as patient access and reliance. The FDA is phasing out the general enforcement discretion approach for LDTs so that IVDs manufactured by laboratories will generally fall under the same enforcement approach as other IVDs.
Compliance with device requirements under the FD&C Act will help assure IVDs offered as LDTs are appropriately safe and effective and put patients in a better position to have confidence in IVDs regardless of where they are manufactured. Device requirements include, among others:
- adverse event reporting,
- establishment registration,
- device listing,
- labeling requirements,
- investigational use requirements,
- quality system requirements, and
- premarket review.
A: The LDT final rule amends the FDA's regulations to make explicit that IVDs are devices under the FD&C Act including when the manufacturer of the IVD is a laboratory. This amendment is not specific to certain types of LDTs, but rather relates to all IVDs manufactured by laboratories. In addition, the preamble to the LDT final rule describes a tailored phaseout policy under which the FDA will provide greater oversight of IVDs offered as LDTs through a phaseout of its general enforcement discretion approach for LDTs over the course of four years. The phaseout policy includes targeted enforcement discretion policies for specific categories of IVDs, including policies for currently marketed IVDs offered as LDTs and LDTs for unmet needs under certain circumstances.
As described in the preamble to the final rule, the FDA intends to exercise enforcement discretion with respect to premarket review and most Quality System (QS) requirements for currently marketed IVDs offered as LDTs that were first marketed before the LDT final rule issued. Additionally, as described in the preamble to the final rule, the FDA intends to exercise enforcement discretion with respect to premarket review and most QS requirements for LDTs manufactured and performed by a laboratory integrated within a health care system to meet an unmet need of patients receiving care within the same health care system. FDA expects compliance with other device requirements for IVDs falling within these policies.
A: The phaseout policy is intended to better protect the public health by helping to assure the safety and effectiveness of IVDs offered as LDTs, while also accounting for other important public health considerations such as patient access and reliance. The targeted enforcement discretion policies described in the preamble to the LDT final rule for certain categories of IVDs, such as the policies for IVDs marketed at the time of issuance of the final rule and LDTs for unmet needs, for example, will help to facilitate patient and health care professionals' access to certain IVDs.
A: The FDA believes that by applying the same general oversight approach to laboratories and non-laboratories that manufacture IVDs, the FDA will reduce regulatory uncertainty, which will give stakeholders more stability, clarity, and confidence, and facilitate investment in the development of innovative IVDs.
A: As discussed in the preamble to the LDT final rule, an LDT is an IVD that is intended for clinical use and that 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 definition does not exclude previously FDA-authorized IVDs that are modified by a laboratory for a use that is outside the IVD's original authorization. Please refer to the preamble to the final rule for a discussion of the phaseout policy, including targeted enforcement discretion policies such as those relating to modifications of an FDA-authorized IVD and to LDTs for unmet needs.
When a healthcare provider orders an IVD for a use that is outside the IVD's authorization, that does not dictate whether the IVD is an LDT or not – i.e., whether it is designed, manufactured, and used within a single laboratory that is certified and meets the regulatory requirements under CLIA to perform high complexity testing. We note that under the FD&C Act, a healthcare practitioner may prescribe or administer a legally marketed device to a patient for any condition or disease within a legitimate healthcare practitioner-patient relationship (see section 1006 of the FD&C Act (21 U.S.C. 396)). This could include situations where the healthcare practitioner specifically orders the use of an IVD outside of its original authorization for an individual patient.
A: LDTs are 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. If an IVD is designed, manufactured, or used in more than one laboratory, it is not an LDT.
FDA's phaseout policy in the final rule applies to "IVDs offered as LDTs." These are IVDs that are manufactured and offered as LDTs by laboratories that are certified under CLIA and meet the regulatory requirements to perform high complexity testing, even if those IVDs do not fall within FDA's traditional understanding of an LDT because they are not designed, manufactured, and used within a single laboratory. FDA adopted this scope because it recognizes that not all laboratories have understood the limited nature of FDA's general enforcement discretion approach and have been offering IVDs based on the approach even when those IVDs do not fit what FDA generally considers to be an LDT.
The targeted enforcement discretion policies for certain new LDTs introduced after May 6, 2024 are all limited to LDTs as defined by FDA in the preamble to the final rule.
IVD Classification
A: FDA classifies IVDs manufactured by laboratories, including laboratory developed tests, in the same way it does other IVD test systems.
Test systems are a set of components--such as reagents, instruments, and other articles--that function together to produce a test result. Test systems include components and are accompanied by instructions for use for sample preparation and pre-analytical processing. Classification of the test system is based on the intended use and risk of the test system.
The most efficient method for an IVD manufacturer to determine the classification of a device type that has already been classified by FDA is by searching the product classification database, included on the resources and references page of the webinar slide deck. Searching FDA's 510(k), PMA, and De Novo databases may also be helpful in understanding what specific IVDs fall within a given device type and how such IVDs are regulated.
An IVD may be of a type that has not already been classified by FDA and, therefore, would not be in the product classification database. As a reminder, device types that have not been classified by FDA previously, and that were not on the market prior to the enactment of the Medical Device Amendments on May 28, 1976, are automatically Class III unless they are reclassified by FDA. If an IVD has not been classified, manufacturers should assess the risk of their IVD and submit the appropriate premarket submission based on the assessed risk. If the manufacturer believes their IVD is high risk, a PMA is likely required. If the manufacturer believes their IVD is low or moderate risk, the IVD may be eligible for de novo classification. The de novo process provides a pathway to class I or class II classification for medical devices for which general controls or general and special controls provide a reasonable assurance of safety and effectiveness, but for which there is no legally marketed predicate device.
A: In general, yes. However, where differences in specimen type or technology between a subject IVD test system and those specified in a classification regulation raise different questions of safety and effectiveness, the classification regulation describing use for a specific specimen type or technology would not be appropriate for a different specimen type or technology.
If you have questions regarding the classification of a specific test, you can submit a pre-submission or 513(g) request.
A: As discussed previously, FDA classifies LDTs the same way it does other IVD test systems. If a laboratory chooses to use one or more components labeled for research use only (RUO) by another manufacturer in its IVD offered as an LDT, then the laboratory is responsible for qualifying such components in its IVD and appropriately listing their IVD test system. As long as the laboratory has implemented a quality system that meets the QS requirements, as applicable, and is able to appropriately manage the quality of these components under that quality system, then the components may be incorporated as part of an IVD offered as an LDT. The RUO-labeled component(s) will be reviewed in the premarket submission for the IVD offered as an LDT, if applicable.
A: In general, LIMS are not included as part of IVD test systems. Rather, LIMS are generally regulated under their own classification regulation (refer to 21 CFR 862.2100, product code JQP) and are Class I, exempt from 510(k) subject to the limitations to exemption under 21 CFR 862.9. In addition, to better understand FDA's regulatory approach for Device Software Functions, see Section V of FDA's Guidance document, Policy for Device Software Functions and Mobile Medical Applications.
A: We recommend laboratories start by searching the product classification database to see if the device type has already been classified by FDA.
If the IVD is of a type that has already been classified by FDA, the database includes the device Class (I, II, or III), the type of submission required (if any), and if applicable, the classification regulation number.
If the IVD is not of a type listed in the classification database, you should assess the risk of your IVD to determine the premarket submission type that is most likely appropriate based on the assessed risk.
- If you believe the IVD is high risk, a PMA is likely required. As a reminder, only about 5% of IVDs currently listed with FDA require a PMA.
- A moderate or low risk device may be eligible for de novo classification.
If after searching FDA's medical device databases and assessing the risk of your IVD you have questions regarding the classification of your IVD, you can seek feedback from FDA via a pre-submission or 513(g) request.
A: As described in the webinar, low risk devices are those that pose minimal potential for harm. Although there are exceptions, the classification of a device generally correlates with its risk category with most Class I devices being low risk.
A: A product code identifies the generic category of a device for FDA. A classification regulation may have multiple product codes associated with it. In this case, classification product codes help to delineate technology and indication subgroups within a regulation. However, a product code is only associated with one classification regulation or no regulation at all. In the latter case, they serve to categorize unclassified or Class III (PMA) devices. Classification product codes are assigned and maintained by the Agency.
For non-510(k)-exempt devices, the submitter of the premarket submission identifies a product code they believe to be appropriate for their device. The proposed product code is reviewed by FDA staff for accuracy during the premarket review. If the proposed product code is incorrect, or a more appropriate product code should be used, the FDA reviewer will change the product code and notify the submitter.
The reviewer will assign a classification product code based on the regulation (if relevant) or the device intended use, indications for use or technology. The most common method of assignment is to use an existing product code from the product classification database. A device will be assigned an existing classification product code when it has the same intended use, indications for use, and relies on technology that does not raise new safety and effectiveness questions. In other words, if the device is determined to be substantially equivalent to the predicate device, it will typically be assigned the predicate device's product code. However, if the proposed device differs significantly from the predicate device with respect to technology, intended use or indications for use or is found not substantially equivalent (NSE), a new product code should be assigned.
In some cases, product code definitions may be updated to accommodate new technology. Additionally, new product codes may be created for tracking purposes for a specific technology or device area.
For additional information on product codes, refer to FDA guidance on Medical Device Classification Product Codes.
A: The original classification of a device can be changed through reclassification, for which multiple processes exist in the FD&C Act. In general, the FDA follows a process for reclassification that includes issuing a proposed order(s), convening a classification panel as appropriate, receiving and considering public comment, and issuing a final order(s).
A: As discussed in the preamble to the LDT Final Rule, FDA’s device classification processes focus on the risk of the IVD itself and availability of controls to address such risk. In classifying devices, FDA considers, among other things, the device’s intended use and indications for use, which includes consideration of the intended patient population. The risk the device poses to the patient and/or the user is a major factor in the class it is assigned. Therefore, FDA considers the risk of a device as it is intended to be used. A manufacturer may design a device in many ways, including as a single test that provides a single result or as a panel of tests that collectively provide a single result.
For example, if a test is intended to detect troponin to aid in the diagnosis of myocardial infarction (MI), the risk would be assessed based on the use of the test in aiding the diagnosis of MI. However, if the troponin test is combined with NT-proBNP and CRP to collectively aid in diagnosing the risk of future MI, the risk would be assessed based on the combined use of the tests in aiding the diagnosis of future risk of MI (even though some of the analytes in the panel are not traditionally associated with assessment for MI).
Laboratories
A: As stated in the preamble to the final rule, FDA recognizes that some small laboratories may be disproportionately impacted by the phaseout of the general enforcement discretion approach for LDTs from a financial perspective. However, the final phaseout policy includes several enforcement discretion policies that the Agency anticipates will reduce costs for laboratories, including small laboratories. 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 as described in section V.B.3 of the preamble to the final rule and 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.
We note that premarket submission requirements for IVDs do not depend on the manufacturer of the IVD (i.e., whether they are a laboratory or non-laboratory manufacturer, the size of the manufacturer).
A: FDA appreciates the important role public health laboratories play in our healthcare system. While the Final Rule does not provide a separate policy for LDTs manufactured and offered by public health laboratories, various enforcement discretion policies detailed in the preamble to the final rule may be applicable to IVDs offered as LDTs by public health laboratories. 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&qout; (i.e., those that were first marketed prior to May 6, 2024) that are not modified or that are modified as described in section V.B.3 of the preamble to the final rule, including those manufactured by public health laboratories. FDA also intends to exercise enforcement discretion for premarket review requirements for LDTs approved, conditionally approved, or within an approved exemption from full technical documentation, under NYS CLEP.
We have also issued draft guidance describing a proposed enforcement discretion policy for certain immediate response tests designed, manufactured, and used within State or local public health laboratories, among other entities. We are seeking comment on this proposal prior to issuing final guidance.
Laboratory Changes
A: If the same laboratory is offering the same LDT before and after publication of the final rule, the LDT generally would fall within the "currently marketed IVDs offered as LDTs&qout; (i.e., those that were first marketed prior to May 6, 2024) policy so long as the IVD is not modified or modified in a way that does not change the indications for use, alter the operating principle, include significantly different technology, or adversely change the performance or safety specifications of the IVD.
Registration & Listing
A: FDA is generally phasing out the general enforcement discretion approach with respect to registration and listing requirements under 21 U.S.C. 360 and part 807 (excluding subpart E). FDA generally expects compliance with R&L requirements by May 6, 2026. Comprehensive registration and listing is critical to inform FDA's understanding of the universe of IVDs offered as LDTs and to help FDA identify, monitor, and address any issues with IVDs offered as LDTs.
We note, however, that tests for public health surveillance are outside the scope of the phaseout policy and that enforcement discretion policies for the following tests extending to R&L requirements: 1976-type tests, certain HLA tests for transplantation, forensic tests, and DoD and VHA LDTs.
A: FDA's regulations define establishment in the registration context as "a place of business under one management at one general physical location at which a device is manufactured, assembled, or otherwise processed." 21 CFR 807.3(c); see also 21 CFR 607.3(c) One general physical location (also referred to as one geographic location) includes separate buildings, and could include multiple laboratories within close proximity if the activities in them are closely related to the same business enterprise, under the supervision of the same local management, and are capable of being inspected at the same time. These must be operating under the same quality management system to be considered a single geographic location for the purposes of establishment registration. FDA considers close proximity to be within a campus setting, within 3 miles driving distance of each other, and within the same state and the same US judicial district court area, as described in FDA's OEI Development and Maintenance Procedure. To the extent a laboratory manufacturer has multiple laboratories in different physical locations, each of these laboratories must be registered separately, unless they meet the attributes listed here. The registered establishment is responsible for compliance with all applicable regulatory requirements for the devices listed under that establishment.
A: Yes, the FDA maintains a database of establishment registrations and device listings, which lists the medical device manufacturers registered with the FDA and medical devices listed with the FDA, on its website. As described in the preamble to the LDT final rule, the FDA generally expects manufacturers of IVDs offered as LDTs to comply with establishment registration and device listing requirements by May 6, 2026. Once a laboratory manufacturer registers its establishment(s) and lists its device(s), the registration and listing information will appear in the FDA's database of establishment registrations and device listings, as it does for all other medical devices. As discussed in the preamble to the LDT final rule, FDA's registration and listing requirements applicable to IVDs offered as LDTs are the same as those applicable to other IVDs and other devices; FDA did not establish any new registration and listing requirements as part of the LDT rulemaking.
A: A registration fee is required upon initial registration and annually thereafter for each establishment that requires establishment registration. The annual registration user fee for each fiscal year is provided on the CDRH registration and listing website. The annual registration fee is announced in the Federal Register prior to the fiscal year beginning that October. The fees are set based on Medical Device User Fee (MDUFA) agreements between FDA and Industry. The current MDUFA program runs through fiscal year 2027. FDA anticipates a new program will be negotiated and authorized for subsequent years.
A: If you do not have a premarket submission number because, under the phaseout policy described in the preamble to the LDT Final Rule, FDA does not expect compliance with premarket review requirements until stage 4 or 5 of the phaseout policy, or because the IVD falls within a targeted enforcement discretion policy described in the preamble to the final rule, enter 2177 into the Premarket Submission Number field when listing the device in the FDA Unified Registration and Listing System (FURLS)/Device Registration and Listing Module (DRLM). FURLS/DRLM will then display a list of product codes specific to enforcement discretion policies described in the preamble to the LDT Final Rule. Please select the product code applicable to the policy under which you are marketing your IVD.
A: Yes, if the test system is an IVD offered as an LDT. For example, a laboratory manufacturing a test system that includes FDA cleared or approved components for an intended use that is not in accordance with the labeled intended use of the FDA cleared or approved components would be expected to register and list the test system.
If a laboratory offers a test system that is legally marketed by another manufacturer for clinical use and offers that test system in accordance with the test system's labeled intended use and without other modification, the laboratory is not acting as a manufacturer of that test system and is not subject to FDA's registration requirements or labeling requirements (among other requirements). However, when a laboratory manufactures its own test system – even if all components of that system, such as assay kits and supplies, are purchased from other vendors/manufacturers (e.g., components, including reagents labeled as analyte specific reagents, or instruments labeled for Research Use Only (RUO)) – that laboratory is responsible for meeting applicable requirements, including establishment registration and device listing requirements, consistent with FDA's expectations for compliance as described in the phaseout policy described in the preamble to the LDT final rule.
Inspections & Audits
A: All domestic and foreign device establishments, including those manufacturing IVDs offered as LDTs, are subject to inspection by FDA. Section 704(a) of the FD&C Act provides FDA authority for inspections, specifically providing authority for duly designated officers or employees of FDA to enter and inspect facilities subject to regulation under the FD&C Act. FDA uses a risk-based evaluation to select device manufacturing facilities for inspection and prioritizes device surveillance inspections that are deemed high-risk based on a variety of specific criteria, including facility compliance history, hazard signals, and inherent risks of the device manufactured at the facility. FDA does not intend to have a different approach for selecting laboratory manufacturing facilities for inspection. Although CLIA inspections occur for laboratories, such inspections do not verify that the tests themselves comply with the requirements of the FD&C Act that are designed to ensure that tests have appropriate assurance of safety and effectiveness for their intended purpose.