Recognized standard
14155 Third edition 2020-07
FDA recognition 2-282 · ISO · Biocompatibility
Key facts
| Recognition number | 2-282 |
|---|---|
| Designation | 14155 Third edition 2020-07 |
| Title | Clinical investigation of medical devices for human subjects - Good clinical practice |
| Standards developer | International Organization for Standardization |
| Specialty area | Biocompatibility |
| Date of entry | Dec 21, 2020 |
| Scope (excerpt) | This document addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the clinical performance or effectiveness and safety of medical devices. For post-market clinical investigations, the principles set… |
At a glance
- None Product codes
- 10–99 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: