FDA guidance
Annual Reports for Approved Premarket Approval Applications (PMA): Guidance for Industry…
FDA guidance · Final · issued Dec 16, 2019
Key facts
| Title | Annual Reports for Approved Premarket Approval Applications (PMA) : Guidance for Industry and Food and Drug Administration Staff |
|---|---|
| Status | Final |
| Issue date | Dec 16, 2019 |
| 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 | Medical Devices |
| Topics | Premarket |
| Docket number | FDA-2006-D-0039 |
| 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