Quote what the software does, without assigning a device class
Key facts
- Human involvement
- YellowClose supervision
- 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 / version
- United States versionUS
Who does what
| Role | What they do |
|---|---|
| Assistance | Do not begin AI assistance until the responsible lawyer has defined and confirmed its permitted scope. |
| Lawyer | Set the scope, supervise the work closely, verify every part relied on, resolve omissions and exceptions, and approve the exact output. |
Checklist
- Verify the applicable jurisdiction and the version of each relevant law, rule or instrument in force at the material time.
- Confirm the output against the client’s instructions and the complete relevant source material, including omissions or contradictions.
- Resolve exceptions and record the responsible lawyer’s approval of the exact output and intended use.