FDA guidance
510(k) Third Party Review Program: Guidance for Industry, Food and Drug Administration…
FDA guidance · Final · issued Mar 12, 2020
Key facts
| Title | 510(k) Third Party Review Program: Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations |
|---|---|
| Status | Final |
| Issue date | Mar 12, 2020 |
| 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-2016-D-2565 |
| 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