FDA guidance
Changes or Modifications During the Conduct of a Clinical Investigation; Final Guidance…
FDA guidance · Final · issued May 28, 2001
Key facts
| Title | Changes or Modifications During the Conduct of a Clinical Investigation; Final Guidance for Industry and CDRH Staff |
|---|---|
| Status | Final |
| Issue date | May 28, 2001 |
| 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
- None 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