Context
The 510(k) submission needed a risk analysis summary and performance test template built to CDRH's expected format, with the subject device's technological characteristics clearly compared against the predicate device's cleared indications.
Regulatory Affairs • US FDA
510(k) Submission - Risk Analysis & Performance Summary
Duration: 4 months • Role: Regulatory Affairs Specialist
Preparing the risk analysis and performance test summary for a 510(k) submission showed that these sections have to be written to the template CDRH actually expects, or the submission comes back with a deficiency letter over formatting, not substance.
Primary Risks Identified
- An FDA Refuse-to-Accept or Additional Information request triggered by an incomplete substantial equivalence comparison or a missing required exhibit
Testing Approach
Compared the subject device against the predicate device's cleared indications and technological characteristics, cited FDA guidance directly, and organized supporting data (risk analysis, performance testing, labeling) into the applicable submission exhibits.
FDA Guidance Documents
Substantial Equivalence Comparison
Submission Exhibits
Outcome
Delivered the risk analysis summary and performance test template required for the 510(k) submission.
Key Lessons
510(k) risk analysis and performance test summaries have to be written to the template CDRH actually expects, or the submission comes back with a deficiency letter over formatting, not substance.
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