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Substantial Equivalence Foundation

Predicate & Substantial Equivalence Strategy

We evaluate whether a proposed predicate can withstand FDA's substantial equivalence analysis, then trace every meaningful technological difference into the evidence needed to support it.

Discuss Your Predicate Strategy

What This Service Is

Predicate selection is not simply a search for the most commercially similar cleared device. A defensible predicate strategy must align intended use, technological characteristics and supporting performance evidence in a way that can sustain FDA review.

When It Is Needed

Before a new 510(k) submission is developed
When multiple potential predicates exist
When the subject device contains meaningful technological differences
When a previous predicate strategy has been questioned by FDA
When the manufacturer needs to understand what evidence will be required to bridge differences

How We Assess Predicate Suitability

Regulation number, product code and classification
Intended use and indications for use
Patient population and anatomical site
Operating principle, materials and energy source
Software functionality and key technology features
Performance characteristics and specifications
Sterilization and patient-contact characteristics
FDA decision summaries, guidance and consensus standards
Performance evidence needed to address differences

Our Regulatory Question

“For every meaningful difference, we ask: Does this difference raise a different question of safety or effectiveness? If not, what evidence is needed to demonstrate that the difference can be appropriately bridged?”

Our Difference

Defensible Argument & Evidence Plan

The objective is not to find the closest-looking device. It is to identify a predicate that supports a coherent, defensible regulatory argument and evidence plan.

Predicate Hierarchy

  • Primary Predicate (Same intended use & tech)
  • Reference Devices (Scientific support for tech differences)
  • Multiple Predicates (When justified by FDA guidance)

Evaluate Your Predicate Options

Avoid 510(k) hold letters with an ironclad substantial equivalence strategy.

Discuss Predicate Strategy

Need to Verify Your Predicate Strategy?

Our senior FDA consultants will audit your predicate choices and substantial equivalence arguments.

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