The meeting types
Pre-Subs, Submission Issue Requests, Study Risk Determinations, and Informational Meetings — voluntary, fee-free, and the cheapest risk-reduction available.
Free field guide · PDF
FDA Q-Sub: Pre-Submissions2026 Field Guide
The meeting types, the PreSTAR template, and the feedback clock — with the pre-submission practice you need.
- Full cycle
- 10–12 wks
- PreSTAR expanded
- Jun 2026
- Feedback
- Day 70–75
Sourced from FDA and verified 2026 publications.
Download the free guide
Enter your work email and we'll send the PDF straight to your inbox.
What's inside
Five pages, zero fluff
Every figure in this guide traces to a named source — FDA and verified 2026 publications.
The PreSTAR template
PreSTAR expanded 1 June 2026 to five new Q-Sub types — plus Human Factors content now inside the nIVD/IVD eSTARs.
The feedback clock
Day 0 → 14 → 70–75 → 90 — the formal feedback cadence, the 5-day rule, and the practical ~6-week meeting wait.
Sources & scope
- fda.gov, eSTAR Program (updated Jun 2026).
- medium.com/@verusip, Understanding the FDA Q-Submission (Q-Sub) Process.
- greenlight.guru, What Devicemakers Need to Know about the FDA Pre-submission Process.
This guide is market-access intelligence, not regulatory or legal advice. Q-Sub practice, PreSTAR templates, and review timelines change — professional review is required before business use.
Market Access Strategy Session
Q-Sub on your 2026 roadmap? Start with the full picture.
A Market Access Strategy Session maps your pre-submission strategy — question design, route confirmation, and PreSTAR readiness.
Professional review is required before business use.
Back to ghmap.io Questions? Talk to our team