FDA guidance
Acceptance of Clinical Data to Support Medical Device Applications and Submissions…
FDA guidance · Final · issued Feb 21, 2018
Key facts
| Title | Acceptance of Clinical Data to Support Medical Device Applications and Submissions: Frequently Asked Questions: Guidance for Industry and Food and Drug Administration Staff |
|---|---|
| Status | Final |
| Issue date | Feb 21, 2018 |
| Center | Center for Devices and Radiological Health |
| Issuing office | Center for Biologics Evaluation and Research, Center for Devices and Radiological Health |
| Communication type | Guidance Document |
| Regulated product | Biologics, Medical Devices |
| Topics | Premarket |
| Docket number | FDA-2013-N-0080 |
| 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