Benefit-Risk Factors to Consider When Determining Substantial Equivalence in 510(k) Submissions
Summary
Final Guidance
510(k)
This FDA guidance document provides recommendations and regulatory information for the medical device industry. It was issued by the Center for Devices and Radiological Health (CDRH) in collaboration with the Center for Biologics Evaluation and Research (CBER).
Document Details
- Issuing Authority: FDA CDRH/CBER
- Status: Final
- Topic Area: 510(k)
- Date: 2018-09-01
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Source: U.S. Food and Drug Administration (FDA). This content is provided for informational purposes. Always refer to the official FDA document for the most current version.
Document Details
Document IDFDA-CDRH-BENEFIT-RISK-FACTORS-TO-CONSIDER-WHEN-DETERMINING-
TypeFDA Guidance
AuthorityFDA CDRH/CBER
Publication Date2018-09-01