Reviewed as of 10 August 2026. Compliance calendars go stale quietly, so this page carries a review date and a status line on every entry rather than a list of dates that may or may not still be operative. Where a requirement has been struck down, delayed, enacted but not yet enforceable, or reported inaccurately elsewhere, the calendar says so.
The 2026 laboratory compliance calendar
28 Dec 2024CLIA personnel requirements, Subpart MCMS revised education and experience criteria for testing personnel, technical consultants, and supervisors, the first substantive update since 1992.
Who it reachesCLIA-certified laboratories performing moderate or high complexity testing.
StatusIn force. Grandfathering applies for personnel in continuous employment in a qualifying role. Labs need documentation showing both the role and the continuity.
31 Mar 2025FDA laboratory developed test rule vacatedThe US District Court for the Eastern District of Texas vacated the rule in its entirety, holding that LDTs are not devices under the Federal Food, Drug, and Cosmetic Act. The FDA did not appeal.
Who it reachesClinical laboratories developing and running their own tests.
StatusVacated. All four phase-in dates are void. Oversight remains with CMS under CLIA. Plans built around the phase-in schedule no longer have a regulatory driver behind them.
18 Dec 2025BIOSECURE Act signed into lawEnacted within the FY2026 National Defense Authorization Act. Restricts federal procurement, contracts, grants, and loans involving biotechnology equipment or services from designated companies of concern.
Who it reachesLabs holding or seeking federal contracts, grants, or loans, including academic and research operations and federal contractors.
StatusEnacted, not yet operative. The prohibitions take effect only after the list is published, guidance is issued, and the Federal Acquisition Regulation is revised.
2 Feb 2026FDA Quality Management System Regulation in force21 CFR Part 820 now incorporates ISO 13485:2016 by reference. The Quality System Inspection Technique was withdrawn the same day.
Who it reachesMedical device manufacturers and the laboratories operating inside their quality systems, including device QC and testing functions.
StatusIn force. Inspections no longer follow QSIT. Quality system records need to map to the ISO 13485:2016 structure rather than the former Part 820 subsystem model.
18 Dec 2026OMB list of biotechnology companies of concernStatutory deadline for the Office of Management and Budget to publish the initial list. Implementing guidance follows within 180 days of publication.
Who it reachesAny lab whose instruments, reagents, sequencing services, or contract research providers could fall inside the designated set, and that touches federal money.
StatusPending. This is the next hard date on the calendar. The list is the trigger for everything downstream. Until it publishes, exposure cannot be assessed with any precision.
No changeISO/IEC 17025 remains at the 2017 editionWidely circulated reports of a 2025 edition with a transition deadline of September 2028 are incorrect. ISO’s catalogue lists ISO/IEC 17025:2017 as the current edition, confirmed at stage 90.93 following systematic review.
Who it reachesAccredited testing and calibration laboratories across environmental, forensic, agricultural, food, and manufacturing QC work.
StatusNo action required. ANAB, A2LA, and PJLA are all assessing against the 2017 edition and none has published a transition policy for a 2025 edition. Verified against ISO and the accreditation bodies’ own documents on 10 August 2026.
Why these frameworks ask for the same four things
Read the calendar as six separate compliance projects and it looks like six separate workloads. Read it as an inspector would and the picture is simpler. CLIA Subpart M, the QMSR, ISO/IEC 17025, and the federal-funding conditions that follow from BIOSECURE all converge on the same four artefacts:
- Personnel qualification records. Who is authorized to perform which procedure, on what basis (degree, credential, documented training, competency assessment), and from what date. Subpart M made this explicit for clinical labs. ISO/IEC 17025 has always asked for it at the method level. The QMSR asks for it through the ISO 13485 competence requirements.
- Audit trail. Who did what, when, and what the value was before it changed. An audit trail that has to be reconstructed from three systems and a technician’s memory is not an audit trail.
- Controlled documents with version history. SOPs, methods, specifications, and quality manuals, each with a current version, an approval record, and evidence of which version was in force on the date a given result was produced.
- Equipment calibration and maintenance status. Which instrument generated which result, what its calibration state was at the time, and when it was last serviced.
A lab that can produce those four things quickly, for any sample, on any date, is most of the way through any inspection on this calendar. A lab that cannot is doing the same evidence-assembly work over again for every framework it operates under, and doing it under time pressure each time.
Where the work actually goes wrong
In our experience the failure is rarely that the records do not exist. It is that they exist in different places. Training records sit with HR, calibration certificates sit in a binder near the instrument, SOP versions sit on a shared drive, and the result itself sits in the LIMS or in a spreadsheet. Each is defensible on its own. Tying them together for a specific result on a specific date is the part that takes three days and produces the finding.
That is the practical case for holding all four in one system. A LIMS that carries personnel authorizations against methods, holds SOPs with version history, tracks instrument calibration state, and writes an audit trail across all of it turns the inspection question from a research project into a query.
What to do before 18 December 2026
The OMB list is the only pending hard date on this calendar, and the useful preparation is not compliance work. It is inventory work:
- List the biotechnology equipment, reagents, sequencing services, and contract research providers your lab uses, by vendor.
- Identify which of your work is performed under a federal contract, grant, or loan.
- Note where those two lists intersect. That intersection is your exposure if a vendor is designated.
- Check the existing Section 1260H list for names already in your supply chain, since entities on that list are a designation pathway under the Act.
Labs with no federal funding and no federal contracts have no exposure under the Act. Labs with both should have the inventory ready before the list publishes rather than after.
Frequently asked questions
Was ISO/IEC 17025 revised in 2025?
No. ISO’s catalogue lists ISO/IEC 17025:2017 as the current edition, confirmed at stage 90.93 following systematic review. Reports of a 2025 edition published in September 2025 with a transition running to September 2028 are not supported by ISO, and neither ILAC before its dissolution nor the Global Accreditation Cooperation has set any such transition. ANAB, A2LA, and PJLA are all still assessing against the 2017 edition.
Is the FDA LDT rule still in effect?
No. The rule was vacated in its entirety on 31 March 2025 and the FDA did not appeal. All four phase-in dates are void. Oversight of laboratory developed tests remains with CMS under CLIA.
What is the next hard compliance date for US laboratories?
18 December 2026, the statutory deadline for OMB to publish the initial list of biotechnology companies of concern under the BIOSECURE Act. Implementing guidance follows within 180 days of publication, and the Federal Acquisition Regulation is revised after that.
Does the BIOSECURE Act restrict my lab today?
Not yet. The Act is enacted but its prohibitions are not operative. They take effect only after the OMB list, the implementing guidance, and the FAR revision are complete, with different timelines depending on how an entity was designated.
Did the CLIA personnel changes make my current staff unqualified?
Not if they were in a qualifying role and their employment has been continuous. The Subpart M update includes grandfathering on that basis. What the lab needs is the documentation that establishes both the role and the continuity.
What changed with the FDA QMSR on 2 February 2026?
21 CFR Part 820 now incorporates ISO 13485:2016 by reference, and QSIT was withdrawn on the same date. Inspections no longer follow the former subsystem model, so quality system documentation needs to be navigable against the ISO 13485 structure.
Keeping this page current
Regulatory status changes between review cycles, sometimes by court order rather than by rulemaking, and sometimes the reporting changes when the requirement has not. This page carries its review date in the opening line for that reason. If a date here conflicts with guidance from your accreditation body or your regulator, theirs governs.
If you are working out how to hold personnel qualifications, audit trail, document versions, and calibration status in one place rather than four, schedule a 30-minute scoping call. We will ask about your accreditation framework, your instruments, and your current record locations, and tell you what a configured deployment would look like for your lab.
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