Recognized standard
Std 2621.2-2022
FDA recognition 13-128 · IEEE · Software/Informatics
Key facts
| Recognition number | 13-128 |
|---|---|
| Designation | Std 2621.2-2022 |
| Title | Standard for Wireless Diabetes Device Security: Information Security Requirements for Connected Diabetes Solutions |
| Standards developer | Institute of Electrical and Electronic Engineers |
| Specialty area | Software/Informatics |
| Date of entry | Dec 19, 2022 |
| Scope (excerpt) | This standard describes the security functional requirements (SFRs), which compose a protection profile (PP), for connected diabetes devices (CDDs). The scope of the PP within the development and evaluation process is described in ISO/IEC 15408.1 In particular, a PP defines the IT security… |
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: