Recognized standard
F3384-21
FDA recognition 8-592 · ASTM · Materials
Key facts
| Recognition number | 8-592 |
|---|---|
| Designation | F3384-21 |
| Title | Standard Specification for Polydioxanone Polymer Resins for Surgical Implants |
| Standards developer | ASTM International |
| Specialty area | Materials |
| Date of entry | May 30, 2022 |
| Device classes | Class 2 |
| Scope (excerpt) | 1.1 This specification covers virgin polydioxanone homopolymer resins intended for use in surgical implants. 1.2 Polydioxanone is commonly abbreviated as PDO, and is alternatively referred to as poly(para dioxanone) or poly(p-dioxanone) with the acronym PPD. Additionally, it may be referred to as… |
At a glance
- 1–9 Product codes
- 1–9 FDA guidance documents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA-recognized consensus standards
The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.
Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date: