FDA guidance
Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling…
FDA guidance · Final · issued Mar 17, 2015
Key facts
| Title | Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling : Guidance for Industry and Food and Drug Administration Staff |
|---|---|
| Status | Final |
| Issue date | Mar 17, 2015 |
| 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-2011-D-0293 |
| Open for comment | No |
| Document on fda.gov | fda.gov |
At a glance
- 100–999 Product codes referenced
- 10–99 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