FDA guidance
Content of Premarket Submissions for Device Software Functions: Guidance for Industry and…
FDA guidance · Final · issued Jun 14, 2023
Key facts
| Title | Content of Premarket Submissions for Device Software Functions: Guidance for Industry and Food and Drug Administration Staff |
|---|---|
| Status | Final |
| Issue date | Jun 14, 2023 |
| Center | Center for Devices and Radiological Health |
| Issuing office | Center for Devices and Radiological Health, Center for Biologics Evaluation and Research, Office of the Commissioner, Office of Clinical Policy and Programs… |
| Communication type | Guidance Document |
| Regulated product | Biologics, Drugs, Medical Devices |
| Topics | Premarket |
| Docket number | FDA-2021-D-0775 |
| 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