FDA guidance
Adaptive Designs for Medical Device Clinical Studies: Guidance for Industry and Food and…
FDA guidance · Final · issued Jul 27, 2016
Key facts
| Title | Adaptive Designs for Medical Device Clinical Studies: Guidance for Industry and Food and Drug Administration Staff |
|---|---|
| Status | Final |
| Issue date | Jul 27, 2016 |
| Center | Center for Devices and Radiological Health |
| Issuing office | Center for Devices and Radiological Health, Center for Biologics Evaluation and Research |
| Communication type | Guidance Document |
| Regulated product | Biologics, Medical Devices |
| Topics | Premarket |
| Docket number | FDA-2015-D-1439 |
| Open for comment | No |
| Document on fda.gov | fda.gov |
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