Recognized standard
F2721-09 (Reapproved 2014)
FDA recognition 15-24 · ASTM · Tissue Engineering
Key facts
| Recognition number | 15-24 |
|---|---|
| Designation | F2721-09 (Reapproved 2014) |
| Title | Standard Guide for Pre-clinical in vivo Evaluation in Critical Size Segmental Bone Defects |
| Standards developer | ASTM International |
| Specialty area | Tissue Engineering |
| Date of entry | Apr 4, 2016 |
| Scope (excerpt) | 1.1 This guide covers general guidelines for the in vivo assessment of tissue-engineered medical products (TEMPs) intended to repair or regenerate bone. TEMPs included in this guide may be composed of natural or synthetic biomaterials (biocompatible and biodegradable) or composites thereof, and may… |
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: