Waived, Moderate and High Complexity Testing
Every test under CLIA has one of three levels, and FDA, not the lab, decides which. The level decides the certificate, the people you need, the QC you run and whether you enroll in proficiency testing. The table below sets the three side by side; the sections explain how FDA scores a test and what changes between moderate and high. Read from 42 CFR 493, FDA and CMS on 23 October 2026.
| Requirement | Waived | Moderate complexity | High complexity |
|---|---|---|---|
| Who sets the level§ 493.17 | FDA: the rule's list, home-use clearance or a waiver by application | FDA scorecard: 12 or less | FDA scorecard: above 12, or not yet categorized |
| Certificate§ 493.5(c) | Any; Certificate of Waiver if waived is all you run | Compliance or accreditation; PPM covers PPM procedures only | Compliance or accreditation |
| Director§§ 493.1405, 493.1443 | Required, no federal qualifications | Moderate complexity qualifications | High complexity qualifications, no master's or bachelor's path |
| Other required rolessubpart M | None | Technical consultant, clinical consultant | Technical supervisor, clinical consultant, general supervisor |
| Testing personnel, minimum§§ 493.1423, 493.1489 | No federal qualifications | High school diploma plus documented training | Associate degree or equivalent education and training |
| Quality control§ 493.1256 | As the manufacturer's instructions say | Subpart K: two control levels each day for quantitative tests, unless IQCP | Same as moderate |
| Proficiency testing§§ 493.801, 493.1236(c) | Not required | Enroll for listed analytes; check accuracy twice a year for the rest | Same as moderate |
| Competency assessment§§ 493.1413, 493.1451 | Not required, good practice | Six procedures, twice in year one, then yearly | Same as moderate |
| Routine survey§§ 493.1775, 493.1777 | None | Every 2 years | Every 2 years |
Your most complex test sets the certificate
CLIA sorts tests, not labs. Every test is waived, moderate complexity (with provider-performed microscopy as a subcategory) or high complexity (§ 493.5(a)), and a lab may run any mix of them (§ 493.5(b)). The lab then takes the certificate its hardest test needs. The CMS brochure: "the certificate a laboratory obtains must be for the most complex category of testing the laboratory performs."
So a family practice running thirty waived tests and one moderate complexity analyzer is a nonwaived lab. The analyzer brings the director qualifications, QC, proficiency testing and surveys in the table above with it.
How FDA categorizes a test
FDA's Center for Devices and Radiological Health sets the level, usually when it clears or approves the test (§ 493.17(c)(1)). Tests on the waived list in the rule, and tests cleared for home use, are waived. Every other test is scored on seven criteria, 1 to 3 each (FDA, CLIA Categorizations):
| Criterion | Score 1 | Score 3 |
|---|---|---|
| 1Knowledge | Minimal; on-the-job instruction is enough | Specialized scientific and technical knowledge is essential |
| 2Training and experience | Minimal training, limited experience | Specialized training, or substantial experience |
| 3Reagents and materials preparation | Stable, prepackaged or premeasured | Labile, or manual weighing or measuring |
| 4Characteristics of operational steps | Automatic or easily controlled | Close monitoring, precise timing or temperature, accurate pipetting |
| 5Calibration, quality control and PT materials | Stable and readily available | Labile or not available |
| 6Troubleshooting and maintenance | Automatic, or clearly described; maintenance seldom needed | Needs decision-making; maintenance needs special skills |
| 7Interpretation and judgment | Minimal | Extensive independent interpretation and judgment |
A score of 2 goes to anything in between. The seven scores are added, so a total runs from 7 to 21, and the rule draws one line: "scores of 12 or less will be categorized as moderate complexity, while those receiving scores above 12 will be categorized as high complexity" (§ 493.17(a)). A test scored 2 on every criterion totals 14 and is high complexity. FDA reads the package insert to score it.
Waived is not a score. A manufacturer whose test was categorized moderate complexity can ask FDA to waive it through a CLIA Waiver by Application; the evidence that takes, and how to find a waived system, is in how a test system becomes waived.
Disagreeing with a category
A test nobody has categorized is high complexity
If a laboratory test system, assay or examination does not appear on the lists of tests in the Federal Register notices, it is considered to be a test of high complexity until PHS, upon request, reviews the matter and notifies the applicant of its decision.
FDA's page says the same in plain words: tests "that have not been CLIA categorized default to high complexity until they have been categorized." FDA publishes its categorizations in the CLIA database, updated weekly, so the working test is simple: if the database has no record for your exact system, plan for high complexity.
Three situations land labs here:
- A test the lab built or changed. A method developed in-house has no FDA categorization. A cleared system run outside its instructions is no longer the system FDA scored; ask your State Agency before you treat it as anything but high complexity.
- A new system not yet listed. FDA adds categorizations at its weekly database update; until then the default applies.
- A name that does not match. FDA asks for a separate CLIA record when a test gets a new trade or distributor name, so search the name on your box. If you cannot find it, CMS's quick start guide says to contact your State Agency.
Takeaway
What moderate and high complexity oblige
Both nonwaived levels carry the same rule book: subparts F, H, J, K, M and Q, plus subpart C or D for the certificate (§ 493.20(b), § 493.25(b)). In practice that is four things.
Certificate
A registration certificate first, then compliance (surveyed by the State Agency or CMS) or accreditation (surveyed by a CMS-approved accreditor), each surveyed every two years. PPM procedures alone can run under the PPM certificate. The certificate is the same for both levels; the fee follows test volume and specialties, not complexity (CLIA fee calculator).
Personnel
Subpart M names the roles and their qualifications. Moderate complexity: a director (§ 493.1405), a technical consultant, a clinical consultant and testing personnel (§ 493.1423). High complexity: a director (§ 493.1443), a technical supervisor, a clinical consultant, a general supervisor and testing personnel (§ 493.1489). The director, "if qualified, may perform the duties" of the other roles or delegate them (§ 493.1407(a), § 493.1445(a)).
Quality control
Subpart K applies to every nonwaived test: at least two control levels each day of testing for a quantitative test, a positive and a negative for a qualitative one, unless the lab runs an approved alternative such as an IQCP (§ 493.1256(d)(3)). The schedule in full: how often to run QC.
Proficiency testing
Enroll in a CMS-approved program for each analyte listed in Subpart I (§ 493.801); for everything else, verify accuracy "at least twice annually" (§ 493.1236(c)). How events are graded: CLIA proficiency testing.
Moderate vs high: what actually changes
Read the table at the top again and the answer is clear: QC, proficiency testing, competency assessment and survey frequency are the same. The difference is people.
- The director. A moderate complexity director can qualify with a master's or bachelor's degree plus experience and 20 CE hours. A high complexity director needs a medical, osteopathic, podiatric or doctoral path, and its experience routes ask for 2 years directing or supervising high complexity testing where the moderate routes ask for 1 year of nonwaived testing (§ 493.1405(b), § 493.1443(b)).
- Two more roles. High complexity adds a technical supervisor and a general supervisor.
- The testing floor. Moderate complexity allows a high school diploma with documented training (§ 493.1423(b)(6)). High complexity starts at an associate degree, or 60 semester hours with set science credits and lab training (§ 493.1489(b)(3)).
One high complexity test changes the staffing
Adding a single high complexity test means a qualified technical supervisor and general supervisor for it, and a director who meets § 493.1443. A compliance lab tells the State Agency of a new specialty or method within 6 months and of a new director within 30 days; an accredited lab tells its accreditor of the new specialty.
Waived tests inside a nonwaived lab
A compliance or accredited lab keeps the waived rules for its waived tests. Subparts J, K and M and the PT enrollment rules "are not applicable to the waived tests", but the lab must still meet § 493.15(e) and the inspection rules (§ 493.20(c), § 493.25(d)). So a waived urine dipstick follows its insert, not the analyzer's two-level daily QC. Waived tests are generally not part of the routine survey, but a surveyor who finds cause pointing to a problem in waived testing should investigate it (SOM § 6140.3).
A waived test stays waived only as the system FDA reviewed. What that means at the bench is in waived still means following the instructions, and what a waiver-only lab owes is in the Certificate of Waiver guide.
How to look up a test system's category
Search FDA's CLIA database by the test system name, open the record, and read the Complexity field: WAIVED, MODERATE or HIGH. Match the system and specimen to your package insert, not just the analyte. The step-by-step, with every field on the record, is in how to look up a test system.
Takeaway