Deciding When to Submit a 510(k) for a Software Change to an Existing Device
Summary
Final Guidance
Software & Digital Health
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: Software & Digital Health
- Date: 2017-10-01
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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-DECIDING-WHEN-TO-SUBMIT-A-510-K-FOR-A-SOFTWARE-CHA
TypeFDA Guidance
AuthorityFDA CDRH/CBER
Publication Date2017-10-01