FDA-recognized standard · Materials
ASTM F754: Standard Specification for Implantable Polytetrafluoroethylene (PTFE) Sheet Tube and Rod Shapes Fabricated from Granular Molding Powders
Yes. FDA recognizes ASTM F754-24 as recognition 8-628, entered 2025-12-22. FDA also lists ASTM F754-08 (Reapproved 2015) (recognition 8-179, transition period ending 2027-12-19).
Recognized editions of ASTM F754
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 8-628 | ASTM F754-24 | 2025-12-22 | Complete | — |
| 8-179 | ASTM F754-08 (Reapproved 2015) | 2019-01-14 | Partial | 2027-12-19 |
What FDA does not recognize in ASTM F754-08 (Reapproved 2015)
Recognition 8-179 is partial. FDA's statement of the extent, verbatim:
Partial recognition. The following part(s) of the standard is (are) not recognized: Appendix X2.2
Regulations
FDA lists these classification regulations against ASTM F754: 21 CFR 872.3930, 21 CFR 878.3300, 21 CFR 878.3550, 21 CFR 878.3590, 21 CFR 878.3680, 21 CFR 878.5010.
Product codes that cite ASTM F754
8 FDA product codes cite ASTM F754, including FTL, FWP, FZD, FZE, GAW.
Source: FDA Recognized Consensus Standards database, snapshot of 2026-09-01. Search every recognition in the Consensus Standards Lookup, or browse all standards with a page.