casemark/fda-device-registration

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