Checklist
FDA 510(k) Submission Checklist
Section-by-section checklist mapped to the current RTA policy, so nothing bounces at intake.
A curated library of submission-ready documents and interactive tools — built for regulatory affairs, quality and clinical teams. Free at launch.
Six categories at launch, spanning the documents regulatory teams rebuild from scratch far too often.
A preview of the resources being prepared for launch. The core shelf ships free — the first pro workbook sits alongside it.
Score your submission against FDA's Refuse-to-Accept criteria — an evidence cell for every row, a readiness rollup per section.
Section-by-section checklist mapped to the current RTA policy, so nothing bounces at intake.
A structured Q-Sub request template with prompts for the questions FDA actually answers.
Annex II & III skeleton with per-section guidance notes and a completeness column.
One sheet from opening to effectiveness check, with aging flags and status rollups.
Clause-by-clause audit checklist with objective-evidence prompts and finding grades.
A lean, auditor-friendly document control SOP skeleton with revision-history scaffolding.
Interactive walkthrough from intended use to device class and likely submission pathway.
Plot review clocks, holds and response windows into a realistic clearance timeline.
No catalog items match that search — try "510(k)", "CAPA" or "audit".
16 more resources are being prepared for launch across all six categories.
Answer a short walkthrough about your submission and get a section-by-section readiness score against FDA's Refuse-to-Accept criteria — before intake does it for you.
Notes on the craft of regulatory documents — what makes a template worth taking, a checklist worth trusting, and a tool worth running.
ISO 13485 Clause 8.2.6 gates release on completed evidence — but a documented concession, not a waived criterion, is the one way around that gate.
Read the note →Section 513(a)(1)(B) lists guidelines among what a special control can be — and FDA's own Class II guidance documents are often that control, not just advice.
Read the note →The UK built its own conformity mark in 2002, but transitional recognition still lets a device reach Great Britain on an EU review, not a UK Approved Body's.
Read the note →The Toolkit is assembled with working regulatory professionals. If you have a template or checklist worth sharing, we'll edit, credit and publish it.
Contribute a template →Tell us what you keep rebuilding by hand — the launch roadmap is shaped by requests from the regulatory community.
Request a tool →One email when the Toolkit launches, plus occasional notes as new resources land. No spam, ever.