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510(k) Substantial Equivalence Toolkit: Stop Guessing What FDA Wants

510(k) Substantial Equivalence Toolkit — predicate comparison, SE summary, performance testing matrix, differences analysis, intended use template, SE checklist.

Get the Toolkit — $347

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What's Included

Predicate Device Comparison Table
Substantial Equivalence Summary Template
Performance Testing Matrix
Technological Differences Analysis Template
Intended Use and Indications for Use Statement Template
Substantial Equivalence Declaration Checklist

Benefits

Predicate comparison table structured to match FDA Section 11 expectations
Five-step SE determination framework aligned with current CDRH guidance
Performance testing matrix links characteristics to FDA-recognized standards
21-point final SE checklist before submission

Is This For You?

This toolkit is designed for teams facing these challenges:

510(k) RTA due to inadequate SE argument
Predicate device selection rationale missing or weak
Technological differences not adequately justified
Intended use vs indications for use distinction unclear

Who This Is For

RA leads preparing first 510(k) submissionRegulatory consultants supporting SE argument developmentStartup founders navigating FDA clearance pathwayEngineers documenting performance testing for 510(k)

Frequently Asked Questions

What makes a strong predicate device selection?

A strong predicate has the same intended use, similar technology or equivalent performance data for differences, and an established FDA clearance record.

Can I use multiple predicates?

Yes. Split predicates are allowed — one for intended use and one for technology. The SE argument must show the combination is substantially equivalent to a legally marketed device.

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Ready to Get Started?

Download immediately after purchase. All templates are editable Word and Excel files.

Get the Toolkit — $347

7-day money-back guarantee