Cruxi
Compliance research
FDA’s acquired supplementary sheets explicitly connect 7-239 to 7-346 and state declaration-acceptance date(s) for the replaced recognition: recognition 7-239: 2027-12-19. Compare the exact edition and recognition limitations with your reports before agreeing the submission evidence or further work.
Evidence retrieved 2026-10-07. Source versions and topic-specific limits are listed below.
Exact FDA recognition records
Read these columns together. A complete recognition is not a device-specific testing instruction. The limitations are the FDA’s public metadata; the licensed standard itself is not reproduced.
| Recognition / edition | Public recognition limitations | Declaration transition context |
|---|---|---|
| FDA 7-239 CLSI EP32-R (Formerly X05-R) Metrological Traceability and Its Implementation; A Report | Complete Complete standard [2] [5] | Exported transition expiration: 12/19/2027 |
| FDA 7-346 CLSI EP32 2nd Edition Implementation of Metrological Traceability in Laboratory Medicine | Complete Complete standard [1] [3] | No expiration date is stated in this acquired export row. That is not a guarantee of indefinite recognition. |
FDA recognition of CLSI EP32-R (Formerly X05-R) [Rec# 7-239] will be superseded by recognition of CLSI EP32 Second Edition [Rec# 7-346]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 7-239] until December 19, 2027. After this transition period, declarations of conformity to [Rec# 7-239] will not be accepted.
Exact statements were reconciled on both acquired sheets and against the old recognition’s exported date. [4] [6]
FDA public recognition metadata describes use of declarations of conformity in support of premarket submissions. A recognition transition is not a universal retesting deadline, a product ban, or proof that this standard applies to your device. The technical differences between licensed editions, adequacy of existing reports, buyer-specific route and final test scope remain incomplete. The comparison below does not reproduce the standard or establish FDA approval.
Method: Exact directed old-to-new statements are reconciled across both acquired sheets and the old export date. No name-similarity mapping or technical-clause inference.
Use this checklist to gather your business or product details before speaking with a specialist. The items below explain what to record and suggest useful supporting documents. You can add your own answers in the editable project brief.
Reconcile each report and declaration against CLSI EP32 2nd Edition and the replaced designation(s) CLSI EP32-R (Formerly X05-R). Record amendments and the exact report/device revision. A similar standard number is not an edition match.
Useful evidence: Report cover, method/edition references, amendments, declarations and device/configuration revision.
Use the complete FDA public limitation text in the comparison table. Map each listed exclusion, where present, to the relevant report sections and obtain a reasoned evidence assessment. Complete recognition still does not determine device applicability.
Useful evidence: Recognition-to-report coverage matrix, excluded-clause assessment and the licensed edition used by your specialist.
Record planned declaration/submission dates against the FDA sheet’s acceptance date(s): recognition 7-239: 2027-12-19. This concerns declarations supporting premarket submissions to the replaced recognition; do not treat it as a blanket deadline to retest or stop selling.
Useful evidence: Submission plan, intended declaration references, dated recognition-sheet check and rationale for the chosen evidence route.
Ask the specialist to assess the actual licensed edition/amendment differences for your design, materials, software and use environment. Separate a documented evidence gap from a changed title. This metadata comparison does not establish which tests changed or must be repeated.
Useful evidence: Edition gap assessment tied to the device and existing evidence, with a bridging rationale and unresolved inputs.
Request a report/recognition reconciliation and a justified gap assessment first. Separate any proposed additional evaluation or testing, samples, methods, deliverables and exclusions; agree them only after applicability and existing evidence are assessed.
Useful evidence: A scoped evidence-assessment quote; separately identified conditional work and report ownership.
Read the official document in context. The audit details identify the precise locators and preserved versions used for this page.
Version not stated by the source · retrieved 2026-10-07
Source key D02 · snapshot 94ccf56dc846c7f6d78d6ad77dc6e87d1803ac3612af01d6894949e34c4a78d8
Version not stated by the source · retrieved 2026-10-07
Source key D02 · snapshot 495b45526fa2bd25da695ec9e67e23509fc49eb488245b7d21a35422a34c88fb
Version not stated by the source · retrieved 2026-10-07
Source key D02 · snapshot 7eeee5dc041c0977d447b63efdd0464b895aa05b77e033a7d1d43cde1af043e7
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