US FDA clearance: 510(k) and De Novo.

A 510(k) submission must demonstrate substantial equivalence to a legally marketed predicate device under Section 510(k) of the Federal Food, Drug, and Cosmetic Act and 21 CFR Part 807 Subpart E. Predicate selection is the single most consequential early decision — the wrong predicate can lead to an AI request or Not Substantially Equivalent (NSE) determination regardless of the quality of other submission elements.

We conduct a structured predicate search across the FDA 510(k) database, review 510(k) summaries and decision summaries for candidate predicates, and identify which predicate or predicate chain best positions your device. We then prepare the substantial equivalence comparison table, documenting intended use, technological characteristics, and performance data on a side-by-side basis. Where differences in technological characteristics exist, we identify what performance data is needed to demonstrate equivalent safety and effectiveness.

For devices without a suitable predicate, or where FDA classification is unclear, we evaluate whether Reclassification (De Novo) under Section 513(f)(2) is the appropriate pathway. De Novo results in a new classification with special controls and creates its own predicate for future 510(k) submitters.

FDA's eSTAR (electronic Submission Template and Resource) format is now required for most 510(k) submissions. The eSTAR template is a structured PDF that walks through each required section: device description, intended use and indications, substantial equivalence discussion, standards conformance, performance testing, biocompatibility, software, sterility and shelf life, and labelling. Each section requires specific content and cross-references to supporting data.

We prepare the complete eSTAR submission package, including a cover letter, summary, device description with images, 510(k) summary per 21 CFR 807.92, and all technical sections. We coordinate performance testing protocols and review test reports before submission. Software submissions require a Software Documentation Level (Basic or Enhanced) determination per FDA's 2021 software guidance; SaMD submissions require additional documentation per the SaMD action plan.

For international submissions where you hold a CE mark or PMDA approval, we assess whether FDA's international recognition programme or relevant third-party review organisation programmes can streamline the review process.

The De Novo pathway under 21 CFR Part 860 Subpart D is used when a device is of a type not previously classified and FDA determines it is low-to-moderate risk. A successful De Novo results in the device being classified into Class I or Class II with specific controls established in the De Novo order, and creates a legally marketed device that can serve as a predicate for future 510(k) submissions.

De Novo submissions require all the elements of a 510(k) plus a proposed classification, proposed special controls, and a summary of a risk-benefit analysis supporting Class II (rather than Class III PMA) classification. FDA's review clock for De Novo is 150 days from acceptance. We prepare the complete De Novo request including the proposed classification regulation language and special controls documentation.