Recognized standard
F3206-17
FDA recognition 15-53 · ASTM · Tissue Engineering
Key facts
| Recognition number | 15-53 |
|---|---|
| Designation | F3206-17 |
| Title | Standard Guide for Assessing Medical Device Cytocompatibility with Delivered Cellular Therapies |
| Standards developer | ASTM International |
| Specialty area | Tissue Engineering |
| Date of entry | Jun 7, 2018 |
| Scope (excerpt) | 1.1 This guide outlines the parameters to consider when designing in vitro tests to assess the potential impact of a delivery device on a cellular product being dispensed. This guide does not provide specific protocols, but rather suggests what should be considered the minimum characterization… |
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: