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Boundary question/US
When do I need a 513(g) instead of assuming my product is not a device?
A boundary-question guide for founders who are unsure whether a product is a medical device or what classification pathway may apply.
Direct answer
Consider a 513(g) discussion when the product boundary is unclear and the cost of guessing is high. This often happens with software, wellness, monitoring, diagnostic-support, or hybrid products where claims matter as much as the technology.
Before asking FDA or a consultant, collect the intended use, claims, users, output, risk, similar products, and why the team thinks it may or may not be a device. That makes the question reviewable.
Use this if
Reader
A founder with a borderline health, software, wellness, diagnostic, or monitoring product
Trigger
The team wants to avoid device obligations but cannot clearly defend the boundary
Blocked decision
Whether to seek formal FDA classification information or a different qualified review path
Useful output
A boundary-evidence checklist before deciding what to ask FDA or a consultant
Do these first
- Write the exact claim language that buyers or users will see.
- Separate wellness, information, monitoring, diagnostic, and treatment-support functions.
- Search similar FDA product codes and cleared devices.
- Prepare one narrow question instead of asking FDA to review the whole business.
What to collect before you ask for help
- Product description and claims.
- User, patient, and care-setting assumptions.
- Software functions, outputs, and risk if relevant.
- Similar products and public classification clues.
Common mistakes
- Assuming a product is not a device because it is software.
- Changing claims informally without preserving the original commercial story.
- Submitting a broad question before narrowing the actual decision.
Public sources to start with