When to ask
When to ask: 513(g) vs the informal mailbox, and when the Request for Designation is the right path.
Free field guide · PDF
FDA 513(g) Classification Requests2026 Field Guide
When to ask, what to submit, and what the answer means — with the classification clarity you need.
- Response
- 60 days
- No exceptions
- Fee
- Ask routes
- 2 paths
Sourced from 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 — verified 2026 publications.
What to submit
What to submit: cover letter, device description, labeling — and the fee rule with no exceptions.
What the answer means
What the answer means: the 60-day response, what it covers — and what it doesn't.
Sources & scope
- massdevice.com, FDA lists final guidance on 513(g) requests for information.
- FDA, User Fees for 513(g) Requests for Information FAQ.
- fda.gov, CDRH Industry Basics: 513(g) Requests for Information.
This guide is market-access intelligence, not regulatory or legal advice. Classification rules, fees, and FDA procedures change — professional review is required before business use.
Market Access Strategy Session
Unclear where your device lands? Start with the full picture.
A Market Access Strategy Session maps your regulatory route — classification strategy, 513(g)/Q-Sub planning, and market access sequencing.
Professional review is required before business use.
Back to ghmap.io Questions? Talk to our team