RA Job Aid Library Toolkit
FDA submission timelines, 510k completeness checklist, regulatory pathway decision tree, 483 response guide, EU MDR milestone timeline, and regulatory glossary — quick-reference tools for daily regulatory affairs work.
What You Get
FDA Submission Timeline Reference Card
Quick-reference card covering FDA review timelines for all major submission types: 510k Traditional (90 days), 510k Special (90 days), 510k Abbreviated (90 days), De Novo (150 days), PMA (180 days), PMA Supplement (180 days), IDE (30 days), Q-Sub (90 days). Includes clock-stop mechanisms, when FDA review timelines restart, and the real-world timeline expectations that differ from statutory review periods.
FDA 510k Submission Completeness Checklist (eSTAR)
Comprehensive completeness checklist for FDA eSTAR 510k submissions. Covers all 12 sections of the 510k eSTAR template with sub-item requirements for each section. Includes the acceptance review criteria FDA uses to determine whether a 510k will be accepted for substantive review, and the most common reasons for Refuse to Accept (RTA) decisions by section.
Regulatory Pathway Decision Tree (Laminated Reference Card Format)
One-page regulatory pathway decision tree for medical device classification and submission pathway determination. Covers Class I/II/III determination, 510k vs De Novo vs PMA vs Exempt pathway selection, the combination product determination question, and the SaMD pathway questions. Formatted as a reference card for use during product development kickoff meetings and regulatory strategy sessions.
FDA 483 Response Strategy Quick Reference Guide
Quick reference guide for FDA 483 observation response strategy. Covers the 15-business-day response deadline, required response elements (acknowledgment, root cause, corrective action plan, implementation timeline), the distinction between a 483 response and a Warning Letter response, and the tone and language that demonstrates a cooperative and credible response to investigators.
EU MDR Key Milestones and Transition Timeline Reference
Quick reference timeline covering EU MDR 2017/745 key dates, transition provisions, and ongoing compliance milestones. Covers EUDAMED activation phases, SSCP requirements by device class, PSUR cycle by class, PMS plan update requirements, and the transition deadlines under Article 120 for legacy MDD devices. Updated for current MDCG guidance.
Medical Device Regulatory Acronym and Term Glossary
Comprehensive glossary of medical device regulatory acronyms and terms covering FDA, EU MDR, ISO, and IMDRF terminology. 200+ entries covering submission types, regulatory roles, QMS terms, clinical terms, and the EU-specific terms that frequently confuse US-trained regulatory professionals working on dual-market strategies. Formatted for quick lookup during submissions and audit preparation.
FAQ
Who are these job aids designed for?
Regulatory affairs professionals at all levels — from RA associates preparing their first 510k to experienced directors who want quick-reference tools for training staff and managing multi-market programs. Each document is designed to be printable or usable as a digital reference during daily regulatory work.
Are these updated for current FDA and EU MDR requirements?
Yes, all content reflects current FDA eSTAR submission format, FDA 2024 guidance updates, and current EU MDR transition provisions as of 2025-2026.
What format are the documents?
Word and PDF-formatted templates optimized for both print and digital use as reference cards.
Ready to get started?
For informational purposes only. Not legal or regulatory advice. Legal