Recognized standard
HN 1-2019
FDA recognition 13-123 · ANSI · Software/Informatics
Key facts
| Recognition number | 13-123 |
|---|---|
| Designation | HN 1-2019 |
| Title | American National Standard Manufacturer Disclosure Statement for Medical Device Security |
| Standards developer | American National Standards Institute |
| Specialty area | Software/Informatics |
| Date of entry | Dec 19, 2022 |
| Scope (excerpt) | Information provided on the MDS2 form is intended to assist professionals responsible for executing security risk assessments in their management of medical device security capabilities. The information on the MDS2 form may be inappropriate for other purposes. |
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: