Recognized standard
2800-1-1:2022
FDA recognition 13-125 · ANSI · Software/Informatics
Key facts
| Recognition number | 13-125 |
|---|---|
| Designation | 2800-1-1:2022 |
| Title | Standard for Risk Concerns for Interoperable Medical Products |
| Standards developer | American National Standards Institute |
| Specialty area | Software/Informatics |
| Date of entry | Dec 19, 2022 |
| Scope (excerpt) | 2.1 This Standard is applicable to interoperable medical products, including assembled systems of interoperable medical products that comprise or are intended to be incorporated into interoperable medical systems within an interoperable environment. 2.2 This standard specifies a baseline set of risk… |
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: