FDA guidance
Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket…
FDA guidance · Final · issued Jun 27, 2025
Key facts
| Title | Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions: Guidance for Industry and Food and Drug Administration Staff |
|---|---|
| Status | Final |
| Issue date | Jun 27, 2025 |
| Center | Center for Devices and Radiological Health |
| Communication type | Guidance Document |
| Topics | Premarket |
| Docket number | FDA-2021-D-1158 |
| Open for comment | No |
| Document on fda.gov | fda.gov |
At a glance
- 10–99 Product codes referenced
- 10–99 Recognized standards referenced
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA guidance documents
FDA guidance documents describe the agency's current thinking on regulatory topics. Drafts are issued for comment before a final version is published.
Source: U.S. Food and Drug Administration (FDA), Guidance Documents