---
title: "Map a software-as-medical-device classification and registration path"
url: "https://ailawframework.com/practice/health-and-medical-law/map-a-software-as-medical-device-classification-and-registration-path"
type: "task"
site: "AI Law Framework"
id: "A32-T1-R6"
practice_area: "Health & Medical Law"
tier: "yellow"
lawyer_review: "required"
last_reviewed: "2026-10-22"
---

# Map a software-as-medical-device classification and registration path

> From the product description, list candidate device classes, registration or exemption paths and evidence still required against the rules the lawyer has named.

Canonical page: https://ailawframework.com/practice/health-and-medical-law/map-a-software-as-medical-device-classification-and-registration-path  
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 | From the product description, list candidate device classes, registration or exemption paths and evidence still required against the rules the lawyer has named. |
| What the lawyer must review | Decide with the regulatory adviser whether the product is a medical device Do not file from a generated pathway |
| Written for / versions | 1 jurisdiction versions below |

## Checking plan

**Lawyer review required**

The responsible lawyer reviews the work against the instructions, sources and intended use.

- What the AI does: Potential support includes extracting and organising information and preparing preliminary structure or wording. Confirm the tool’s capability and permitted scope.
- What the lawyer does: Set the scope, verify the evidence, resolve exceptions and approve the final output for its intended use.
- Who reviews: Responsible lawyer with competence in the matter
- Basis: Suggested checking approach based on the task guidance. Complete the assessment for the actual tool, information and jurisdiction.
- Why: The plan reflects the described work and review requirements. Policy colours are not used to determine permission or checking.

## Checks the lawyer makes

1. Trace every relied-on figure to its source, confirm dates and assumptions, and independently recalculate totals or derived amounts.
2. Confirm that the actual tool, feature and processing terms permit use of this information, including access, retention, training and disclosure conditions.
3. Obtain and inspect the relevant current official register or search result. Confirm identities, interests and the date and scope of the search.
4. Verify the applicable jurisdiction and the version of each relevant law, rule or instrument in force at the material time.
5. Confirm the output against the client’s instructions and the complete relevant source material, including omissions or contradictions.
6. Resolve exceptions and record the responsible lawyer’s approval of the exact output and intended use.

## Notes

- Confirm the required checking with the responsible lawyer before work starts. The checking approach does not establish permission to use AI.

## Jurisdiction versions

| Jurisdiction | Level |
| --- | --- |
| [United States](https://ailawframework.com/practice/health-and-medical-law/map-a-software-as-medical-device-classification-and-registration-path/united-states.md) | Yellow |

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