$247 — Standard Tier

Predicate Research Toolkit: 510k Database Search and Comparison Templates

Predicate Research Toolkit — 510k database search protocol, predicate evaluation matrix, FDA-format comparison table, split predicate justification, performance comparison worksheet, and predicate strategy memo.

Get the Toolkit — $247

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What's Included

510k Database Systematic Search Protocol
Predicate Device Candidate Evaluation Matrix
Predicate Comparison Table Template (FDA Format)
Split Predicate Justification Template
Predicate Performance Standard Comparison Worksheet
510k Predicate Strategy Memo Template

Benefits

Systematic search protocol documents predicate research process to FDA reviewer standard
FDA-format comparison table generates the 510k predicate section directly from the completed template
Split predicate template covers the two-predicate approach with FDA guidance citations
Strategy memo supports internal decisions and 510k submission predicate narrative

Is This For You?

This toolkit is designed for teams facing these challenges:

Predicate search not systematic or documented, causing FDA questions about search methodology
Predicate comparison table not in FDA-preferred format causing reviewer requests for additional information
Split predicate justification missing required rationale for using two predicates
Predicate too old or too different causing substantial equivalence challenges

Who This Is For

RA associates conducting first predicate search for 510k submissionRegulatory consultants building substantial equivalence arguments for clientsProduct development teams identifying regulatory pathway early in designCompanies preparing 510k submissions for Class II devices

Frequently Asked Questions

How many predicates can I use in a 510k?

You can use multiple predicates. Split predicate uses one for intended use and another for technological characteristics. Document your predicate selection rationale thoroughly.

Can I use an NSE device as a predicate?

No. Only SE-determined, 510k-cleared, De Novo-authorized, or pre-amendments devices can serve as predicates.

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Ready to Get Started?

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

Get the Toolkit — $247

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