Recognized standard
F2211-13
FDA recognition 15-40 · ASTM · Tissue Engineering
Key facts
| Recognition number | 15-40 |
|---|---|
| Designation | F2211-13 |
| Title | Standard Classification for Tissue Engineered Medical Products (TEMPs) |
| Standards developer | ASTM International |
| Specialty area | Tissue Engineering |
| Date of entry | Jul 9, 2014 |
| Scope (excerpt) | 1.1 This classification outlines the aspects of tissue engineered medical products that will be developed as standards. This classification excludes traditional transplantation of organs and tissues as well as transplantation of living cells alone as cellular therapies. 1.2 This classification does… |
At a glance
- None 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: