FDA guidance
Checklist of Information Usually Submitted in an Investigational Device Exemptions (IDE)…
FDA guidance · Final · issued Oct 9, 1996
Key facts
| Title | Checklist of Information Usually Submitted in an Investigational Device Exemptions (IDE) Application for Refractive Surgery Lasers [excimer] |
|---|---|
| Status | Final |
| Issue date | Oct 9, 1996 |
| 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-2020-D-0957 |
| Open for comment | No |
At a glance
- None Product codes referenced
- None 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