- What is a CLIA Categorization?
- What are the CLIA Categorization Criteria?
- When Does a Test Receive a CLIA Categorization?
- When to Submit a CLIA Record (CR)
- How to Prepare a CR Submission
- FDA Actions for CRs
- Is There a User Fee for CRs?
- Resources/Contact Us
The FDA categorizes clinical laboratory tests by their complexity—from the least to the most complex: waived tests, moderate complexity tests, and high complexity tests.
CLIA categorization is determined after the FDA has cleared or approved a marketing submission, or upon request for legally marketed devices, as described in the FDA guidance Administrative Procedures for CLIA Categorization. Tests that are waived by regulation under 42 CFR 493.15(c), or cleared or approved for home use, are categorized as waived. Otherwise, the FDA determines the test’s complexity by reviewing the package insert test instructions, and using a criteria “scorecard” to categorize a test as moderate or high complexity (42 CFR 493.17). Each test is graded for level of complexity by assigning scores of 1, 2, or 3 for each of the seven criteria on the scorecard.
A score of 1 indicates the lowest level of complexity, and a score of 3 indicates the highest level. The scores for the 7 criteria are added together and tests with a score of 12 or less are categorized as moderate complexity, while those with a score above 12 are categorized as high complexity.
Following initial categorization, 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.
Note: Test systems that have not been CLIA categorized default to high complexity until they have been categorized (42 CFR 493.17).
1 - Knowledge
- Score 1. (A) Minimal scientific and technical knowledge is required to perform the test; and (B) Knowledge required to perform the test may be obtained through on-the-job instruction.
- Score 3. Specialized scientific and technical knowledge is essential to perform preanalytic, analytic or postanalytic phases of the testing.
2 - Training and experience
- Score 1. (A) Minimal training is required for preanalytic, analytic and postanalytic phases of the testing process; and (B) Limited experience is required to perform the test.
- Score 3. (A) Specialized training is essential to perform the preanalytic, analytic or postanalytic testing process; or Substantial experience may be necessary for analytic test performance.
3 - Reagents and materials preparation
- Score 1. (A) Reagents and materials are generally stable and reliable; and (B) Reagents and materials are prepackaged, or premeasured, or require no special handling, precautions or storage conditions.
- Score 3. (A) Reagents and materials may be labile and may require special handling to assure reliability; or (B) Reagents and materials preparation may include manual steps such as gravimetric or volumetric measurements.
4 - Characteristics of operational steps
- Score 1. Operational steps are either automatically executed (such as pipetting, temperature monitoring, or timing of steps), or are easily controlled.
- Score 3. Operational steps in the testing process require close monitoring or control, and may require special specimen preparation, precise temperature control or timing of procedural steps, accurate pipetting, or extensive calculations.
5 - Calibration, quality control, and proficiency testing materials
- Score 1. (A) Calibration materials are stable and readily available; (B) Quality control materials are stable and readily available; and (C) External proficiency testing materials, when available, are stable.
- Score 3. (A) Calibration materials, if available, may be labile; (B) Quality control materials may be labile, or not available; or (C) External proficiency testing materials, if available, may be labile.
6 - Test system troubleshooting and equipment maintenance
- Score 1. (A) Test system troubleshooting is automatic or self-correcting, or clearly described or requires minimal judgment; and (B) Equipment maintenance is provided by the manufacturer, is seldom needed, or can easily be performed.
- Score 3. (A) Troubleshooting is not automatic and requires decision-making and direct intervention to resolve most problems; or (B) Maintenance requires special knowledge, skills, and abilities.
7 - Interpretation and judgment
- Score 1. (A) Minimal interpretation and judgment are required to perform preanalytic, analytic and postanalytic processes; and (B) Resolution of problems requires limited independent interpretation and judgment.
- Score 3. (A) Extensive independent interpretation and judgment are required to perform the preanalytic, analytic or postanalytic processes; and (B) Resolution of problems requires extensive interpretation and judgment.
Note: A score of 2 will be assigned to a criteria heading when the characteristics for a particular test are intermediate between the descriptions listed for scores of 1 and 3.
Test systems receive an initial CLIA categorization from the FDA after the test system is cleared/approved/licensed/granted following review of a marketing submission. A test system manufacturer may also submit a standalone request for categorization for legally marketed tests that do not have a marketing submission, such as those that are Class I or Class II 510(k)-exempt. Within FDA, CLIA categorization is conducted by the Center for Devices and Radiological Health (CDRH).
The FDA tracks CLIA categorizations through CLIA Record (CR) submissions.
There are two types of CRs:
- Concurrent: CRs automatically created upon receipt of in vitro diagnostic (IVD) marketing submissions (e.g., 510(k), De Novo, PMA, HDE) reviewed by CDRH.
- Standalone: CRs created upon request for CLIA categorization of legally marketed IVD test systems for which a new CDRH marketing submission is not needed, or CRs created following a cleared/approved/licensed/granted marketing submission for tests reviewed by other FDA Centers.
- In cases where the marketing submission is reviewed by another FDA Center (e.g., Center for Biologics Evaluation and Research (CBER)), the other Center will notify CDRH at the time of clearance/approval/licensing/granting of the test. At that time, FDA will create a CR to track CDRH’s categorization of the test.
Submitting a standalone CR is recommended for the following situations:
- Changes to the trade name, manufacturer, or distributor name of a legally marketed test, including adding a new distributor and/or trade name;
- New test systems (new reagent and instrument combinations) covered by the FDA guidance Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices; and
- New IVDs that are exempt from premarket notification.
- Review the following guidance:
- Assemble the application. Recommended contents of a CR include, but are not limited to, the following:
- A signed and dated cover letter that:
- Indicates the submission as a CLIA Record (CR) submission or CLIA categorization request
- Identifies at least one contact person (include name, title, phone number, and email address)
- The correspondent should be a representative of the marketing submission (e.g., 510(k), PMA) holder or 510(k)-exempt manufacturer for the assays for which CLIA categorization is requested (as listed in the FDA Registration & Listing Database), or a letter from the assay marketing submission holder/manufacturer authorizing the correspondent should be included in the submission.
- Includes the submission reason (e.g., new trade name, manufacturer or distributor name; new assay and instrument combination under the Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices (RRP); or 510(k)-exempt test system)
- Identifies the test systems for which CLIA categorization is requested, or where in the submission the test systems are identified (such as an accompanying spreadsheet or table)
- For CLIA categorization purposes, a test system commonly includes both an instrument/analyzer and an assay, but may be a unitized device (e.g., a manually read lateral flow test), a manual assay without an instrument, or a reagent-free instrument.
- The following information should be included for each instrument/analyzer or assay:
- The manufacturer name, trade name, and distributor name (if applicable) as included on current labeling
- The marketing submission number (e.g., 510(k), PMA number, De Novo #), or the product code and/or regulation number for 510(k)-exempt devices
- Current labeling with instructions for use. (e.g., package insert(s), operator’s manual(s), application sheet(s) for RRP. Container/box labeling does not need to be included.). Or a reference to a previous CDRH submission where this labeling was provided (e.g., 510(k), PMA, De Novo, CR, CW) if the labeling has not changed.
- A signed and dated cover letter that:
- Submit the CR:
- CR submissions for in vitro diagnostic devices are reviewed by the FDA’s Center for Devices and Radiological Health (CDRH). A CR 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 encourages submission of a validated eCopy.
- 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 submission and the assigned CR tracking number. The CR tracking number begins with the letters "CR" 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., CR210001).
- Interactive Review
- If additional information is needed to complete a CLIA categorization request, the FDA will request this information using the Interactive Review process. For more information about Interactive Review, please see the guidance Types of Communication During the Review of Medical Device Submissions.
- Final Decision
- For Concurrent CRs, the FDA will attempt to notify applicants of the final decision within two weeks of the final decision for the parent marketing submission. For Standalone CRs, the FDA will attempt to notify applicants of the final decision within 30 days of receipt of the CR submission.
- A CR final decision may be a notification of CLIA categorization, a notification that CLIA categorization is not needed, a notification of insufficient information to complete categorization, a notification that a new premarket submission is needed, or withdrawal by the applicant.
- Categorization is effective as of the date of the written notification to the manufacturer (see 42 CFR 493.17(c)(1)(ii)). If CLIA Categorization has been completed for a CR, the categorization will also be included in the public CLIA Database at the next weekly update.
No. There is no MDUFA User Fee for a CR.