AI-drafted 510(k), EU MDR Technical File, and change-assessment packages. Predicate rationale, testing summaries, labeling, cybersecurity, SBOM, and PCCP sections generated from your DHF — reviewed, versioned, and defensible.
The FY2026 510(k) user fee is $26,067 ($6,517 for small businesses) but internal preparation cost runs $20K–$500K+ depending on complexity, with testing at 40–60% of total. The biggest lever isn't the user fee — it's the labor cost of rebuilding submissions from scratch. Alterra AI cuts 60–80% of drafting effort by building a controlled AI layer over your DHF, predicate library, and prior submissions.
Every submission for a growing product portfolio replays the same work:
Indexes prior 510(k)s, cleared predicates, and public 510(k) summaries. Drafts the substantial equivalence rationale with side-by-side comparison tables. Reviewer edits and signs.
Pulls testing reports, labeling, IFU, and risk file content from your DHF. Assembles the eSTAR-aligned package with hyperlinked cross-references. Redlines the gaps.
Generates the cybersecurity section aligned to FDA's 2023 cybersecurity guidance and current SBOM conventions. Flags stale components and open CVEs before submission.
Runs proposed changes through the "Deciding When to Submit a 510(k)" decision tree. Produces the assessment record. Reviewer approves the call — with the reasoning captured.
| Metric | Before (typical) | After (target) | Source of estimate |
|---|---|---|---|
| Drafting hours per 510(k) | 400–800 hrs | 80–200 hrs | Alterra AI project estimate |
| Time from kickoff to submission | 4–8 months internal prep | 6–14 weeks | Alterra AI project estimate |
| Change assessment cycle | 2–4 weeks | 2–4 days | Alterra AI project estimate |
| RTA-triggering gaps at first review | 2–5 typical | < 1 (target) | Alterra AI project estimate |
| FDA AI-letter response prep | 30–60 hrs | 8–15 hrs | Alterra AI project estimate |
Ranges based on public FY2026 cost data (Complizen, MedDeviceGuide, i3CGlobal) and Alterra project modeling. Individual results depend on predicate history and submission complexity.
What a diligence team will pull: your submission pipeline, first-cycle clearance rate, and average time from CE-mark or clearance to first commercial revenue. AI-driven submission ops directly improves all three — and shows up as a shorter revenue-onset curve in the acquirer's model.
Alterra AI's submission workflow aligns to FDA's eSTAR requirements, the 2023 Cybersecurity in Medical Devices guidance (including SPDX/CycloneDX SBOM conventions), FDA's 2017 "Deciding When to Submit a 510(k)" guidance, EU MDR Annex II/III for Technical Files, and PCCP guidance for AI/ML-enabled devices. Every AI-drafted section is a controlled record with a human reviewer and signed approval.
Class II SMB with 1–5 submissions in the pipeline over 24 months, prior 510(k) history to seed the predicate library, product portfolio expansion or line extensions, or a first-in-class device requiring pre-sub strategy work.
Pre-IDE / novel Class III on the PMA path (different scope), or a company without a working DHF (build design controls first via the QMS/QMSR business case).
48-hour read-only review of your DHF, most recent submission, and change log. Gap punch list and RTA-risk score. Fixed-fee proposal within 5 business days.
Book the 48-hour Assessment