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fda-device-registration

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.

personAuthor: jakexiaohubgithub
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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

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