fda-device-registration

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

1. Establishment details — legal name, FEI number, physical/mailing addresses, business activities
2. Owner/operator information — legal names, titles, contact details, signature authority
3. Device inventory — product codes, classifications, intended uses, listing numbers, 510(k) numbers
4. US agent info (foreign establishments only) — name, address, phone, email
5. 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