FDA guidance
Use of International Standard ISO 10993-1, "Biological evaluation of medical devices…
FDA guidance · Final · issued Sep 8, 2023
Key facts
| Title | Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" : Guidance for Industry and Food and Drug Administration Staff |
|---|---|
| Status | Final |
| Issue date | Sep 8, 2023 |
| Center | Center for Devices and Radiological Health |
| Issuing office | Center for Devices and Radiological Health, Center for Biologics Evaluation and Research |
| Communication type | Guidance Document |
| Regulated product | Biologics, Medical Devices |
| Topics | Premarket |
| Docket number | FDA-2013-D-0350 |
| Open for comment | No |
| Document on fda.gov | fda.gov |
At a glance
- 100–999 Product codes referenced
- 100–999 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