DeviceBridge · How it works
Specialist Claude agents draft every artifact in a 510(k) submission. A named regulatory lead e-signs at nine human Gates. A tamper-evident hash chain records every step. The result is speed without a loss of rigor — first-submission timelines measured in weeks, with each milestone still signed by a person and verifiable by an inspector.
Human-in-the-loop
The platform halts at each gate until a named regulatory lead e-signs with WebAuthn 2FA. Each sign-off produces a manifest binding signer, timestamp, intent, and the SHA-256 of the exact artifact reviewed — and lands in the hash-chained audit. Why it matters: an FDA decision is only as defensible as the human accountability behind it, and these nine gates are that accountability, recorded mechanically.
Class, product code, regulation, pathway — and the CDRH-vs-CBER routing decision. The blood / cellular-therapy / vaccine branch fires here, because a misroute caught at Gate 1 saves the ~60 days a wrong-center submission costs.
Primary and secondary predicates plus reference devices, each pulled from a live FDA database query — never a fabricated K-number.
Pre-Sub questions and the proposed test plan, when a Q-Submission is used to de-risk the program with FDA before filing.
The side-by-side comparison table, the five-decision-point SE narrative, and indications-for-use alignment. A multi-signer gate.
Bench, biocompatibility, software, EMC, animal, clinical, and human-factors scopes, each mapped to FDA-recognized consensus standards.
All section drafts reviewed together before assembly, so the submission is coherent rather than a collection of independently-acceptable parts.
"eSTAR Complete" verification plus a passing RTA checklist, with size limits enforced before upload. The template version is captured and the submission is locked to it.
Form FDA 3601 PIN logged and payment reconciled against the FRBNY confirmation before any submission can proceed.
The final go / no-go to upload via the CDRH Portal. No agent ever submits to FDA without this explicit signed release.
The specialist-agent pipeline
Each agent is narrow and accountable. A single Orchestrator agent dispatches them, owns submission state, and owns the audit trail. Agents draft and analyze; humans decide at the gates.
The Pathway Classifier returns Class I/II/III, product code, regulation, and pathway (Traditional / Special / Abbreviated 510(k), De Novo, 513(g)), and decides CDRH vs CBER.
Why it matters · RA gets a defensible starting point and an early misroute catch.
The Predicate Finder queries the live FDA 510(k) and De Novo databases; the SE Analyst builds the comparison table and the five-decision-point narrative, refusing split-predicate constructions.
Why it matters · QA gets predicate citations that resolve to a real, snapshotted FDA record.
Device description, indications for use (Form 3881), test plan, biocompatibility (ISO 10993-1), software documentation, cybersecurity (§524B with a CycloneDX SBOM), labeling, and the 510(k) Summary — drafted in parallel across all 26 eSTAR sections.
Why it matters · RA reviews complete drafts with gap analysis, not blank templates.
The eSTAR Assembler fills the FDA's dynamic Acrobat template and the RTA Validator runs the FDA's own acceptance checklist deterministically before upload.
Why it matters · QA sees the RTA verdict before the user fee is paid, not after a refusal.
The Submission Orchestrator handles the Form 3601 user fee, uploads via selector-resilient CDRH Portal RPA, captures the K-number from the Acknowledgement Letter, and tracks the review clock.
Why it matters · RA gets Day 7 / 15 / 60 / 90 milestones and cliff alerts from real FDA correspondence.
First-of-kind capabilities
These are the capabilities a skeptical RA or QA reviewer should probe hardest. Each is stated as a concrete mechanism and what it buys the regulatory team.
Source-of-truth doctrine
Predicate citations, product codes, K-numbers, and consensus-standard references are looked up against live FDA databases at draft time. The query, the result hash, and the result snapshot are logged. An agent that cannot ground a claim refuses to emit it.
Why it matters · No fabricated regulatory fact can ever enter a submission.
AI provenance
Every agent run records its tool calls, the sources it grounded against, and token telemetry. The reasoning path is reconstructable after the fact.
Why it matters · An inspector can reconstruct exactly what each agent did and why.
Mock-FDA rehearsal
A mock CDRH Portal emulates the FDA's response surface — Acknowledgement, Hold, and AI Letters. The first real submission is effectively the second; the first run is a full rehearsal.
Why it matters · The team meets failure modes in rehearsal, not on the real clock.
Refuse-to-Accept analyzer
The highest-frequency RTA / Technical Screening rules run before upload (10 of 26 today; the balance is scoped). The verdict is deterministic, not a model guess.
Why it matters · QA predicts "eSTAR Complete" before paying the user fee.
eSTAR assembly
The dynamic Acrobat eSTAR template is filled and its internal verification status confirmed, with attachments managed under the per-attachment and total-size limits.
Why it matters · RA sees a real "eSTAR Complete" PDF, not a hand-wave.
180-day cliff alerting
AI Request, Hold, RTA Hold, and Technical Screening Hold all auto-delete a submission at day 181. Alerts fire at T-60 / 30 / 14 / 7 / 3 / 1 with escalation, so the deadline is never silently missed.
Why it matters · The most expensive failure in 510(k) — a missed cliff — is engineered out.
Cross-product audit chain
DeviceBridge files 510(k) device submissions to CDRH. Its sister platform, INDBridge, files IND submissions for drugs and biologics to CDER and CBER over the FDA ESG. A sponsor running a combination product or a companion diagnostic gets one cross-product audit chain spanning both regimes — hash-linked across products, with a verifier that walks both ledgers and confirms integrity end to end.
Why it matters: a combination-product program no longer has two disconnected compliance stories. It has one chain an inspector can verify across the device 510(k) and the drug IND in a single pass.
See it on a live workspace
We will run a device through classification, predicates, section authoring, the RTA pre-check, and a mock-FDA rehearsal — and show you the audit chain and tool-use traces behind every step.
