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

[ ] 21 CFR Part 807 registration requirements
[ ] QSR compliance (21 CFR Part 820) where applicable
[ ] Device classifications accurately represented
[ ] US agent designated (foreign establishments — 21 CFR 807.40)
[ ] Claimed exemptions cited with regulatory authority and justification
[ ] MDR reporting obligations acknowledged (21 CFR Part 803)

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