fda-device-registration

name	fda-device-registration
language	en
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

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
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

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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