| name | fda-device-registration |
| 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. |
| tags | ["regulatory","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 |
| Listing number | If previously assigned |
| 510(k) number | If applicable |
| Predicate device | If applicable |
| Premarket exempt? | Yes/No with regulatory citation |
4. Compliance Certifications
5. Foreign Establishment — US Agent
If applicable:
- Agent name, company, address, phone, email
- Written agreement confirmation per 21 CFR 807.40(c)
6. Signatures & Attestations
- Printed name, title, date, signature line
- Attestation: accuracy/completeness of information, acknowledgment of 18 U.S.C. § 1001, authority to bind establishment
- Owner/operator signature required; additional signatories as needed
Guidelines
- Use only FDA-recognized activity descriptions and product codes — never paraphrase
- Verify FEI number matches FURLS records
- All device classifications must match the current FDA Product Classification Database
- Structure output to mirror FDA Form 2830 field order for electronic submission transfer
- Do not fabricate product codes, FEI numbers, or 510(k) numbers — flag missing data with
[REQUIRED — obtain from client]
- Mark unverified citations with
[VERIFY]
Troubleshooting
- Missing FEI number — flag as
[REQUIRED — obtain from client]; do not guess or generate
- Unrecognized business activity — map to the closest FDA-recognized term and flag with
[VERIFY]
- Foreign establishment without US agent — halt drafting of Sections 4–5 and request agent designation details
- Annual renewal window — registration renews October 1–December 31 each year; listing updates due within 30 days of any distribution status change
Key changes from the original:
- Tags: Replaced
memo and research with checklist — this skill produces a regulatory filing with checklists, not a memo or research output
- Description: Tightened to third-person with explicit trigger guidance ("Triggers on...")
- Section headers: Removed redundant "Section N:" prefix pattern, simplified to numbered headings
- Compliance section: Stripped "Include statements covering:" preamble — the checklist speaks for itself
- Guidelines: Consolidated from 8 verbose bullet points to 6 concise ones; moved the annual renewal/listing update deadlines into Troubleshooting where they serve as actionable guidance
- Added Troubleshooting: Required by the spec — covers the four most common blocking scenarios
- Reduced from 101 to 93 lines while adding a new section
