---
title: "Quote what the software does, without assigning a device class"
url: "https://ailawframework.com/practice/health-and-medical-law/map-a-software-as-medical-device-classification-and-registration-path/united-states"
type: "task_jurisdiction_version"
site: "AI Law Framework"
id: "A32-T1-R6-US"
practice_area: "Health & Medical Law"
tier: "yellow"
lawyer_review: "required"
jurisdictions: ["US"]
last_reviewed: "2026-10-22"
---

# Quote what the software does, without assigning a device class

> Quote the product description from the file, including any statement that it diagnoses, treats, or drives a clinical decision. Do not assign a device class and do not name a registration path.

Canonical page: https://ailawframework.com/practice/health-and-medical-law/map-a-software-as-medical-device-classification-and-registration-path/united-states  
Last reviewed: 2026-10-22

Site index for agents: https://ailawframework.com/llms.txt

## Key facts

| Fact | Value |
| --- | --- |
| Practice area | [Health & Medical Law](https://ailawframework.com/practice/health-and-medical-law.md) |
| Human involvement | Yellow: Lawyer and AI draft together |
| How AI is used | Quote the product description from the file, including any statement that it diagnoses, treats, or drives a clinical decision. Do not assign a device class and do not name a registration path. |
| What the lawyer must review | You classify the product only after you open the regulation. The device page that was requested did not return the classification text, so no class and no premarket path is stated. Comment 8 to Rule 1.1 requires attention to the benefits and risks of the technology you use. Formal Opinion 512 requires independent verification before you rely on a generated classification. Model Rule 1.4(b) is the explanation you give the client. A class number that is not in an opened regulation is not guessed. |
| Written for | United States |
| Applies to | [Map a software-as-medical-device classification and registration path](https://ailawframework.com/practice/health-and-medical-law/map-a-software-as-medical-device-classification-and-registration-path.md) |

## Checking plan

- What the AI does: Quote the product description from the file, including any statement that it diagnoses, treats, or drives a clinical decision. Do not assign a device class and do not name a registration path.
- Basis: Checked against the linked sources on 22 October 2026. Confirm the current instrument before reliance.

## Notes

- A marketing sentence is not a classification.
- Do not fill a registration form. None was opened.

## Sources

- [ABA Model Rule 1.1, Comment 8](https://www.americanbar.org/groups/professional_responsibility/publications/model_rules_of_professional_conduct/rule_1_1_competence/comment_on_rule_1_1/) (checked 2026-10-22)
- [ABA Formal Opinion 512, Generative Artificial Intelligence Tools (29 July 2024)](https://www.americanbar.org/content/dam/aba/administrative/professional_responsibility/ethics-opinions/aba-formal-opinion-512.pdf) (checked 2026-10-22)
- [ABA Model Rule 1.4, Communications](https://www.americanbar.org/groups/professional_responsibility/publications/model_rules_of_professional_conduct/rule_1_4_communications/) (checked 2026-10-22)

*Practice guidance for planning and review. Confirm current primary sources and the requirements of the actual matter. This is general information, not legal advice.*