Supporting medical device organisations with regulatory strategy, documentation and evidence coordination for Class II device 510(k) submissions to the US FDA.
Whether you are planning a new US market submission or reviewing an existing 510(k) package, DnA provides structured support from initial pathway assessment through submission preparation. The focus is on building consistent documentation backed by appropriate device and performance evidence.
Assessing device classification, product code and 510(k) pathway
Developing predicate and substantial equivalence strategy
Identifying testing, validation and supporting evidence requirements
Preparing and reviewing eSTAR submission documentation
Review the device pathway, intended use, classification and potential predicates to establish a clear foundation for the 510(k) submission.
Coordinate device information, performance testing, risk, labelling and applicable validation evidence into a consistent submission package.
Prepare and review required eSTAR content, supporting documents and submission records for client-authorised filing.
Support the preparation of focused regulatory questions, relevant device information and supporting documentation for FDA Pre-Submission interactions.
DnA Regulatory Solutions helps medical device teams organise the different elements of a 510(k) into one consistent submission. The approach connects device characteristics, predicate comparisons and supporting evidence so that gaps can be identified and addressed before filing.
Predicate comparison and substantial equivalence documentation
Performance, risk, labelling and validation evidence coordination
Submission consistency review and support for FDA questions
Built Around Submission Readiness:
A strong 510(k) requires more than completing forms. DnA helps teams organise supporting evidence, maintain consistency across submission documents and prepare a clear package for FDA review.
DnA assists with regulatory pathway assessment, predicate strategy, substantial equivalence documentation, testing requirements, eSTAR preparation and supporting submission evidence.
The predicate forms an important part of demonstrating substantial equivalence. Device characteristics, intended use and technological differences need to be carefully assessed and documented.
Yes. Support can include helping teams organise responses and supporting evidence when FDA questions or additional information requests arise.
Bring predicate strategy, testing, device information and supporting records together in a submission package prepared for FDA review.