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.
No provision of the FD&C Act sets a 510(k) decision deadline. The 90-day figure is MDUFA's negotiated goal, and its clock stops while FDA waits on the sponsor.
Read the note →An IRB's SR or NSR finding isn't binding on FDA. A Study Risk Determination Q-Submission asks FDA to put its risk view in writing before enrollment starts.
Read the note →GUDID stores only the device identifier, never the production identifier. 830.310 sets the record's attributes; 830.320 sets a real clock for updating them.
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.