Classification and predicate analysis
Product code, regulation, class, 510(k) status, legally marketed predicates and reference-device landscape with documented selection criteria.
FDA 510(k) Submission
FDA 510(k) submission support for medical device software.
We help SaMD and software-enabled device teams select and test the predicate strategy, align performance evidence to the comparison, and prepare a controlled eSTAR package for FDA review.
Selected clients
Healthcare teams we have supported
Scope and deliverables
510(k) work included in the service.
Scope is tailored after classification and predicate feasibility are assessed. A 510(k) is appropriate only when substantial equivalence can be supported.
Substantial-equivalence strategy
Comparison of intended use, indications, technological characteristics, differences, risk implications and the evidence needed to resolve new questions.
Evidence and standards matrix
Applicable special controls, guidance, consensus standards and performance tests mapped to claims, risks and predicate differences.
Software and cybersecurity sections
Software description, architecture, level-of-concern documentation where applicable, V&V, risk, interoperability, cybersecurity and AI/ML content.
eSTAR submission package
Controlled drafting and assembly of administrative, labeling, device-description, comparison and performance content in the current eSTAR.
FDA review support
Acceptance review checks, interactive-review coordination and structured responses to additional-information requests.
Ways to work together
Choose the support your team needs.
End-to-end submission
We coordinate the submission plan, author agreed sections, manage interfaces and support review through FDA’s decision.
Predicate and gap sprint
A focused assessment before testing begins, producing pathway rationale, comparison tables and a prioritized evidence plan.
Independent readiness review
A structured challenge of an existing eSTAR and evidence set against current requirements and the claimed equivalence.
How it works
Our process.
- 1
Establish the route
Confirm device status, classification, submission type and predicate feasibility.
- 2
Lock the argument
Define claims, comparisons, differences and the objective evidence needed for each.
- 3
Build and verify
Close gaps, draft content, assemble eSTAR and complete consistency and traceability reviews.
- 4
Submit and respond
Support CDRH Portal filing and coordinate accurate, controlled answers during review.
Regulations, standards and guidance considered
21 CFR Part 807 Subpart EFDA eSTARFDA Refuse to Accept PolicyFDA QMSRISO 13485:2016ISO 14971IEC 62304IEC 62366-1
Frequently asked questions
Questions teams ask before they begin.
What makes a predicate suitable?+
A predicate must be legally marketed and support the same intended use; technological differences must not raise different questions of safety and effectiveness and must be addressed by appropriate evidence. Commercial similarity alone is insufficient.
How long does FDA review take?+
FDA has performance goals, but elapsed time varies with acceptance, interactive review, additional-information requests and sponsor response time. Planning should separate FDA review time from preparation, testing and clock stops.
Is clinical data always required?+
No. Many 510(k)s rely on bench, analytical, software and usability evidence. Clinical data may be needed when nonclinical evidence cannot resolve relevant questions created by the claims, technology or predicate differences.
Must a 510(k) use eSTAR?+
FDA generally requires 510(k) submissions to CDRH or CBER to use the current eSTAR and be sent through the CDRH Portal, subject to limited stated exemptions. The current template and instructions should be verified immediately before filing.
Does clearance approve every future software change?+
No. Manufacturers must assess changes under applicable FDA guidance and quality-system controls. Some changes can require a new 510(k); the decision and rationale should be documented.
Can you guarantee clearance?+
No. FDA determines substantial equivalence. We can define and execute a rigorous scope, identify material gaps and support review, but cannot promise an agency outcome.
Start with the product you have