US FDA Medical Device Consultant &
510(k) Premarket Notification

Before testing begins or a dossier is drafted, we establish the device's regulatory identity: classification, regulation number, product code, applicable controls, exemption status and likely premarket pathway. This early assessment prevents costly work from being built around the wrong FDA route.

We structure the 510(k) around the substantial equivalence decision FDA must make. Classification, predicate eligibility, technological differences, evidence requirements and labeling are aligned before the eSTAR submission is built.

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.

We design the testing plan backward from the FDA decision the evidence must support — challenging configuration, worst-case rationale, standards, acceptance criteria and whether the resulting data will actually answer the regulatory question.

We treat eSTAR as the container for the regulatory argument — not as the strategy itself. The dossier is built only after pathway, predicate and evidence requirements are clear, then checked for cross-section consistency.

We determine which uncertainties are worth taking to FDA, frame focused questions and provide enough technical context for FDA feedback to be actionable before major testing or submission decisions are locked.

For novel or higher-risk devices, we build the regulatory strategy around the evidence FDA will need to reach a classification or approval decision, integrating risk, controls, non-clinical evidence, clinical evidence and FDA interaction.

We deconstruct each FDA question to identify the underlying regulatory concern, trace it back through the submission and determine whether the real issue is evidence, study design, predicate logic, labeling, consistency or presentation.

We test whether the quality system can produce objective evidence when an FDA investigator follows a real transaction through the organization — not merely whether the required SOPs exist.

We provide US Agent representation as part of a broader regulatory interface — supporting FDA communication, registration coordination and escalation when the foreign manufacturer needs a reliable US regulatory contact.

We support initial registration, device listing and annual maintenance while checking that the administrative registration activity remains aligned with the device's actual regulatory status and market authorization pathway.

We assess the regulatory impact of device changes before implementation — focusing on whether the modification affects intended use, technological characteristics, safety, effectiveness, performance or the basis of the original clearance.

We plan regulatory evidence across target markets so common testing and technical documentation can be leveraged where scientifically and regulatorily appropriate, while market-specific gaps are identified early.