FDA guidance
Off-The-Shelf Software Use in Medical Devices: Guidance for Industry and Food and Drug…
FDA guidance · Final · issued Aug 11, 2023
Key facts
| Title | Off-The-Shelf Software Use in Medical Devices: Guidance for Industry and Food and Drug Administration Staff |
|---|---|
| Status | Final |
| Issue date | Aug 11, 2023 |
| Center | Center for Devices and Radiological Health |
| Issuing office | Center for Devices and Radiological Health |
| Communication type | Guidance Document |
| Regulated product | Medical Devices |
| Topics | Premarket |
| Docket number | FDA-2019-D-3598 |
| 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