FDA guidance
Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and…
FDA guidance · Final · issued Apr 17, 2010
Key facts
| Title | Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems - Guidance for Industry and FDA Staff |
|---|---|
| Status | Final |
| Issue date | Apr 17, 2010 |
| 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-2020-D-0957 |
| 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