Recognized standard
F2529-13
FDA recognition 15-44 · ASTM · Tissue Engineering
Key facts
| Recognition number | 15-44 |
|---|---|
| Designation | F2529-13 |
| Title | Standard Guide for in vivo Evaluation of Osteoinductive Potential for Materials Containing Demineralized Bone (DBM) |
| Standards developer | ASTM International |
| Specialty area | Tissue Engineering |
| Date of entry | Apr 4, 2016 |
| Device classes | Class 2 |
| Scope (excerpt) | 1.1 This guide covers general guidelines to evaluate the effectiveness of DBM-containing products intended to cause and/or promote bone formation when implanted or injected in vivo. This guide is applicable to products that may be composed of one or more of the following components: natural… |
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: