Regulatory Affairs • US FDA

510(k) Submission - Predicate Device Comparison

Duration: 9 months • Role: Regulatory Affairs Specialist

Updating the Special 510(k) documents based on new information showed that organizing a submission by exhibit (summary, performance data, labeling) up front saves far more review time than assembling the sections after the technical work is done.

Context

New information required updating the Special 510(k) documents, including the substantial equivalence comparison against the predicate device. The submission needed the predicate's FDA number and confirmed equivalence of indications for use before it could move forward.

510(k) FDA Predicate Device Comparison

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 Predicate Device Research Submission Exhibits

Outcome

Completed the predicate device comparison, citing the predicate's FDA number and confirming equivalence of indications for use.

Key Lessons

Organizing a 510(k) submission by exhibit (summary, performance data, labeling) up front saves far more review time than assembling the sections after the technical work is done.

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