FDA guidance
Guidance for the Content of Premarket Notifications for Conventional and Antimicrobial…
FDA guidance · Final · issued Sep 11, 1994
Key facts
| Title | Guidance for the Content of Premarket Notifications for Conventional and Antimicrobial Foley Catheters |
|---|---|
| Status | Final |
| Issue date | Sep 11, 1994 |
| 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 |
At a glance
- 10–99 Product codes referenced
- 1–9 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