| name | fda-device-registration |
| title | FDA Establishment Registration & Device Listing |
| description | Drafts FDA Establishment Registration and Device Listing documents compliant with 21 CFR Part 807. Structures filings with establishment details, owner/operator information, device inventories, compliance certifications, and signature blocks mirroring FDA Form 2830. Triggers on initial registrations, annual renewals, listing updates, or foreign establishment filings requiring US agent designations. |
| author | CaseMark |
| author_url | https://github.com/CaseMark/skills/tree/main/skills/legal/fda-device-registration |
| license | Apache-2.0 |
| version | 0.1.0 |
| execution_mode | open |
| jurisdiction | us |
| practice | life-sciences |
| language | en |
| tags | ["drafting","checklist"] |
FDA Establishment Registration & Device Listing
Drafts a 21 CFR Part 807 registration and device listing document structured for FDA submission via FURLS.
Prerequisites
- Establishment details — legal name, FEI number, physical/mailing addresses, business activities
- Owner/operator information — legal names, titles, contact details, signature authority
- Device inventory — product codes, classifications, intended uses, listing numbers, 510(k) numbers
- US agent info (foreign establishments only) — name, address, phone, email
- Prior submissions — previous registration numbers, listing numbers, any pending 510(k)s
Output Structure
Document Header
| Field | Content |
|---|
| Title | Establishment Registration and Device Listing |
| Regulatory basis | 21 CFR Part 807 |
| FDA Form | 2830 (confirm current version at FDA.gov) |
| Preparation date | [Date] |
| Filing type | Initial / Annual Renewal / Update |
1. Establishment Information
- Legal owner name (must match corporate records)
- FEI number
- Physical address and mailing address (if different)
- Phone, fax, email
- Business activities — use only FDA-recognized terms: Manufacturer, Contract Manufacturer, Repackager/Relabeler, Specification Developer, Reprocessor of Single-Use Devices, Foreign Manufacturer, Sterilizer, Component Manufacturer
2. Owner/Operator Details
For each responsible party:
- Full legal name and title
- Signature authority designation
- Contact information
- Confirmation of legal authority to bind establishment
3. Device Listing
For each device:
| Field | Requirement |
|---|
| Device name | Common/trade name |
| FDA product code | 3-letter code from FDA classification database |
| Classification | Class I, II, or III |
| Intended use | Technical description aligned with labeling |
