Cruxi
Compliance research
FDA’s acquired supplementary sheets explicitly connect 13-36 to 13-143 and state declaration-acceptance date(s) for the replaced recognition: recognition 13-36: 2028-07-02. 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 13-36 AAMI TIR 45:2012 Guidance on the use of AGILE practices in the development of medical device software | Complete Complete standard [3] [5] | Exported transition expiration: 07/02/2028 |
| FDA 13-143 AAMI TIR45:2023 Guidance on the use of AGILE practices in the development of medical device software | Complete Complete standard [2] [4] | No expiration date is stated in this acquired export row. That is not a guarantee of indefinite recognition. |
FDA recognition of AAMI TIR 45:2012 [Rec# 13-36] will be superseded by recognition of AAMI TIR45:2023 [Rec# 13-143]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 13-36] until July 2, 2028. After this transition period, declarations of conformity to [Rec# 13-36] will not be accepted.
Exact statements were reconciled on both acquired sheets and against the old recognition’s exported date. [1] [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 AAMI TIR45:2023 and the replaced designation(s) AAMI TIR 45:2012. 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 13-36: 2028-07-02. 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 e025d5b8535167f159b85de86155d93827af17587b8ee1b22dbd5d2f42496029
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 af76d18ea0b684100ec0fc67c63ae9b9c72773e738ad10a36459d0c2ad206771
Confirm the facts, scope and contact preference before sharing your project. Preparing this page sends no provider outreach.