510(k) STRATEGY

Picking the Wrong Predicate Costs You 12 Months.
Pick the Right One.

Complete 510(k) predicate selection and substantial equivalence strategy toolkit. Search framework, comparison matrix, SE argument templates — structured for FDA review.

6 Strategy Documents Included

01
Predicate Search Strategy Template
Structured framework for conducting and documenting a predicate search in the FDA 510(k) database. Covers search parameters, selection criteria, predicate comparison matrix, and rationale documentation for the chosen predicate device.
02
Predicate Comparison Matrix
Side-by-side comparison template for evaluating substantial equivalence across intended use, technological characteristics, performance data, and labeling. Pre-formatted for direct inclusion in the 510(k) submission SE section.
03
Technological Characteristics Differences Analysis
Structured analysis template for documenting technological differences from the predicate, assessing whether differences raise new safety/effectiveness questions, and providing performance data justification.
04
510(k) Regulatory Pathway Decision Guide
Decision tree and pathway selection framework: Traditional 510(k), Abbreviated 510(k), Special 510(k), De Novo, and PMA. Includes product classification lookup methodology and predicate availability assessment.
05
Performance Testing Requirements Worksheet
Template for identifying required performance tests based on device type, predicate data, and applicable FDA guidance documents. Links test requirements to SE argument sections.
06
Predicate Strategy Summary Memo
Executive summary template for documenting predicate selection rationale for design history file and pre-submission meetings. Ready for use in Q-Sub background packages.

$347 One-Time. Instant Download.

All 6 documents delivered immediately after purchase. Editable Word/Markdown format.

"We spent three weeks picking a predicate. This toolkit would have cut that to two days."

RA Manager
Class II Startup

"The comparison matrix format is exactly what FDA wants to see in the SE section."

Regulatory Affairs Director
Mid-size Device Company

FAQ

Does this help with De Novo as well?
Yes. The regulatory pathway decision guide covers the De Novo process for devices with no predicate, including the criteria FDA uses to grant De Novo authorization.
Is this useful for pre-submission meetings?
Yes. The predicate strategy summary memo is specifically designed for inclusion in Q-Sub background packages where you are seeking FDA feedback on predicate selection.
What if we have multiple potential predicates?
The predicate comparison matrix supports multiple predicate comparison and split predicate analysis where different predicates are used for intended use and technological characteristics.
Legal · This toolkit is for informational and educational purposes only. Not legal or regulatory advice. Use at your own risk.