FDA guidance
Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket…
FDA guidance · Final · issued Sep 25, 2018
Key facts
| Title | Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) with Different Technological Characteristics: Guidance for Industry and Food and Drug Administration Staff |
|---|---|
| Status | Final |
| Issue date | Sep 25, 2018 |
| 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 |
| Docket number | FDA-2014-D-0900 |
| Open for comment | No |
| Document on fda.gov | fda.gov |
At a glance
- None Product codes referenced
- None Recognized standards referenced
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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