FDA guidance
Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR)…
FDA guidance · Final · issued Oct 10, 2023
Key facts
| Title | Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment: Guidance for Industry and Food and Drug Administration Staff |
|---|---|
| Status | Final |
| Issue date | Oct 10, 2023 |
| Center | Center for Devices and Radiological Health |
| Issuing office | Center for Devices and Radiological Health |
| Communication type | Guidance Document |
| Regulated product | Medical Devices, Radiation-Emitting Products |
| Topics | Premarket |
| Docket number | FDA-2019-D-2837 |
| Open for comment | No |
| Document on fda.gov | fda.gov |
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