This is a ready-to-use checklist for two biocompatibility standards transitions that land inside the same three-week window: USP <87>/<88> becomes official 1 December 2026, retiring the legacy Class I-VI plastics classification, and FDA’s transition period for the withdrawn ISO 10993-17:2002 toxicological risk assessment method closes 20 December 2026. Replace every <<FILL: ...>> placeholder, work the checklist against your actual material and device-constituent inventory, and route the completed record through document control. A worked filled specimen follows the template. Verify each cited standard against the current source before you rely on it.
Control header
| Field | Entry |
|---|---|
| Checklist number | <<FILL: CHK-EL-ID>> |
| Product(s) / material(s) in scope | <<FILL>> |
| Performed by / date | <<FILL>> |
| Reviewed by (Quality) / date | <<FILL>> |
| Approved by / date | <<FILL>> |
Background: what is changing and when
- USP <87> Biological Reactivity Tests, In Vitro and <88> Biological Reactivity Tests, In Vivo are revised, official 1 December 2026. The revision retires the Class I-VI plastics classification (in practice only Class VI certificates were still being requested) and replaces it with a “Pharmaceutical Grade Polymeric Materials” designation evaluated under expanded in vitro <87> methods, with <1031> as the risk-based framework for any further biological evaluation. The animal-based <88> testing that used to anchor a Class VI claim is largely retired.
- ISO 10993-17:2023 (second edition, the Toxicological Screening Limit method) was recognized in part by FDA on 18 December 2023. Declarations of conformity to the withdrawn 2002 first edition are accepted only until 20 December 2026, after which only the 2023 edition is recognized.
Neither is a device-only concern. Any drug, biologic, or combination product with a plastic or elastomer product-contact material, or a device constituent carrying its own toxicological risk assessment, is in scope for one or both.
Items
| # | Item | Pass / Fail / N/A | Evidence | Comments |
|---|---|---|---|---|
| 1 | A current inventory exists of every product-contact plastic and elastomer material and every device constituent with its own toxicological risk assessment | |||
| 2 | For each material in scope, the current supplier certificate of analysis or specification has been reviewed for a “USP Class VI” citation | |||
| 3 | Where a “USP Class VI” citation was found, the supplier has been contacted for an updated certificate referencing the revised <87>/<88>/<1031> framework | |||
| 4 | Internal component specifications, incoming inspection criteria, and supplier quality agreements have been reviewed for a “Class VI” requirement and updated to cite the revised chapters | |||
| 5 | Purchasing and supplier quality templates (RFQs, supplier questionnaires, audit checklists) that ask for a “Class VI certificate” have been updated | |||
| 6 | For each device constituent with a toxicological risk assessment, the assessment has been checked for a citation to ISO 10993-17:2002 | |||
| 7 | Where a 2002-edition citation was found, the risk assessment has been reworked to the 2023 TSL method (screening exposure against the Toxicological Screening Limit before a full margin-of-safety calculation) | |||
| 8 | The reworked risk assessment’s exposure basis (assumed vs. experimental release kinetics) is documented and consistent with the leachables data actually available | |||
| 9 | Any submission, technical file, or design history file referencing either retired scheme has been identified for an update on its own regulatory timeline | |||
| 10 | Change control records exist for every specification, certificate, or risk assessment updated as a result of this checklist | |||
| 11 | Quality Assurance has confirmed no open item remains past its transition date without a documented, risk-justified interim rationale |
Acceptance criteria
- Every product-contact material and device-constituent assessment in scope has been checked against both transitions, not just the one that happens to be top of mind.
- Every “Fail” or open item has an owner, a target date, and a change control record, and no target date falls after the relevant transition date without a documented interim rationale reviewed by Quality.
- The checklist itself, once completed, is retained as evidence that the transition was actively managed rather than discovered after the fact.
References
USP General Chapters <87>, <88>, and <1031> (revised biological reactivity and biocompatibility framework, official 1 December 2026). ISO 10993-17:2023, Biological evaluation of medical devices, Toxicological risk assessment of medical device constituents, and the FDA recognition transition for the withdrawn 2002 first edition (transition closes 20 December 2026). See Extractables and Leachables for the underlying framework and the worked AET calculation.
Confirm the current version and effective date of each standard before you rely on it; official dates for chapters still in ballot can move.
Filled specimen
The following shows the checklist completed for an example prefilled syringe combination product. Values are illustrative.
| # | Item | Pass / Fail / N/A | Evidence | Comments |
|---|---|---|---|---|
| 1 | Material inventory exists | Pass | Material inventory MI-EL-014, rev 3 | Plunger stopper, needle shield, barrel coating |
| 2 | Certificates reviewed for “Class VI” | Fail | Plunger stopper COA dated 2023 cites Class VI | Needs updated certificate |
| 3 | Supplier contacted for updated certificate | Pass | Supplier RFQ SQ-2026-441 sent 2026-09-10 | Response due before 1 Dec 2026 |
| 4 | Internal specs updated | Fail | Spec SPEC-COMP-0231 still cites Class VI | Change control CR-2026-118 opened |
| 5 | Purchasing templates updated | Pass | RFQ template rev 5 references <87>/<88>/<1031> | |
| 6 | Toxicological risk assessments checked for ISO 10993-17:2002 | Fail | TRA-DEV-009 cites 2002 edition | Rework required |
| 7 | Risk assessment reworked to 2023 TSL method | In progress | Toxicology draft due 2026-11-15 | Screening against TSL expected to clear 2 of 3 flagged constituents |
| 8 | Exposure basis documented | Pass | Experimental release kinetics from leachables study LS-2025-07 used | |
| 9 | Submissions/DHF checked | Pass | No open submission references either retired scheme | |
| 10 | Change control records exist | Pass | CR-2026-118, CR-2026-119 | |
| 11 | QA confirms no undocumented open item | Pass | Interim rationale not needed; both items on track to close before their dates |
Interpretation: two genuine gaps were found (item 2/4 and item 6/7), both already have an owner, a change control record, and a target date ahead of the relevant transition date. This is what “actively managed” looks like on inspection: not zero findings, but every finding tracked to closure before the standard actually changes underneath the product.
Common inspection findings this checklist prevents
- A supplier certificate or internal specification still citing “USP Class VI” months after the revised chapters became official, with no record that anyone checked.
- A device-constituent toxicological risk assessment left on the withdrawn ISO 10993-17:2002 method past the FDA transition date, discovered only when a reviewer asks about it.
- The transition treated as the supplier’s problem to solve unprompted, with no internal review of specifications, RFQ templates, or existing assessments.
How to adapt this checklist
- Set your checklist number and list every product and material in scope.
- Work through the 11 items against your actual inventory, specifications, and risk assessments, not from memory.
- Open a change control record for every gap found, with an owner and a target date ahead of the relevant transition date.
- Have Quality Assurance confirm closure, or a documented, risk-justified interim rationale, before the transition date arrives.
- Retain the completed checklist as evidence of active management for the next audit or inspection.