Recognized standard
23217 First Edition 2024-02
FDA recognition 6-502 · ISO · General Plastic Surgery/General Hospital
Key facts
| Recognition number | 6-502 |
|---|---|
| Designation | 23217 First Edition 2024-02 |
| Title | Injection systems for self-administration by paediatric patients - Requirements and guidelines for design |
| Standards developer | International Organization for Standardization |
| Specialty area | General Plastic Surgery/General Hospital |
| Date of entry | May 29, 2024 |
| Device classes | Class 2 |
| Scope (excerpt) | This document provides requirements and guidelines on the development of drug delivery systems intended for self-administration of medicinal products by the specific demographic group of paediatric patients who are performing some or all use steps required for their intended use. Use steps include… |
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: