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Fda Device Registration

Draft FDA Device Registration Filings in Minutes

12 minutes with CaseMark

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Workflow

Fda Device Registration

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Workflow

Fda Device Registration

Overview

CaseMark's FDA Device Registration skill automates the drafting of Establishment Registration and Device Listing documents compliant with 21 CFR Part 807. It transforms your establishment details, device inventories, and owner/operator information into structured filings that mirror FDA Form 2830, ready for review and submission through FURLS.

Preparing FDA Establishment Registration and Device Listing documents is a meticulous, time-consuming process. Regulatory teams must manually compile establishment details, device inventories with correct product codes and classifications, owner/operator information, and compliance certifications—all while ensuring strict adherence to 21 CFR Part 807 formatting requirements. Errors or omissions can delay filings and jeopardize market access.

CaseMark automates the entire drafting process by ingesting your establishment and device data and generating fully structured registration documents that mirror FDA Form 2830. The AI applies FDA-recognized terminology, organizes device listings with proper classification references, and includes all required sections from establishment information to signature blocks—letting your regulatory team focus on review rather than document assembly.

How it works

  1. 1. Upload your establishment details, device inventory, and owner/operator information

  2. 2. AI structures the filing in full compliance with 21 CFR Part 807 and FDA Form 2830 format

  3. 3. Review the generated registration and device listing for accuracy

  4. 4. Export the completed document in DOCX or PDF for FURLS submission

What you get

  • Document Header & Filing Type Designation

  • Establishment Information Section

  • Owner/Operator Details & Signature Authority

  • Device Listing Inventory with Product Codes & Classifications

  • US Agent Designation (Foreign Establishments)

  • Compliance Certifications & Signature Blocks

What it handles

  • Generates complete establishment registration documents mirroring FDA Form 2830

  • Structures device listing inventories with product codes, classifications, and 510(k) references

  • Populates owner/operator details with signature authority designations

  • Handles foreign establishment filings with US agent designation sections

  • Supports initial registrations, annual renewals, and listing updates

  • Produces compliance certification and attestation blocks ready for execution

Required documents

  • Establishment Details

    Legal name, FEI number, physical and mailing addresses, business activities, and contact information for the establishment

    .pdf, .docx, .xlsx

  • Device Inventory Records

    Product codes, device classifications, intended uses, listing numbers, 510(k) numbers, and predicate device information for all devices to be listed

    .pdf, .docx, .xlsx

  • Owner/Operator Information

    Legal names, titles, contact details, and signature authority designations for all responsible parties

    .pdf, .docx

Supporting documents

  • US Agent Designation

    Name, address, phone, and email of the designated US agent for foreign establishment filings

    .pdf, .docx

  • Prior FDA Submissions

    Previous registration numbers, listing numbers, and any pending 510(k) submissions for reference

    .pdf, .docx

  • Corporate Authorization Records

    Board resolutions or corporate documents confirming signature authority for binding the establishment

    .pdf, .docx

Why teams use it

Reduce registration document preparation time from days to minutes with AI-powered drafting

Ensure structural compliance with 21 CFR Part 807 and FDA Form 2830 formatting requirements

Eliminate common filing errors with automated field validation and FDA-recognized terminology

Maintain consistent documentation across initial registrations, annual renewals, and listing updates

Questions

Does this generate documents compliant with current FDA Form 2830 requirements?

Yes. CaseMark structures every output to mirror the FDA Form 2830 layout and 21 CFR Part 807 requirements, including all required fields for establishment information, device listings, and owner/operator details. We recommend confirming the current form version at FDA.gov before submission.

Can it handle foreign establishment filings that require a US agent?

Absolutely. CaseMark automatically includes US agent designation sections when processing foreign establishment filings, capturing the agent's name, address, phone, and email as required by FDA regulations.

Does it support annual renewals and listing updates, or only initial registrations?

CaseMark supports all filing types—initial registrations, annual renewals, and listing updates. The AI adapts the document structure and required fields based on the filing type you specify.

How does the device listing section handle multiple devices?

CaseMark generates a structured inventory entry for each device, including common/trade name, FDA product code, classification (Class I, II, or III), intended use, listing number, 510(k) number, and predicate device information where applicable.

Can I use this for both Class I and Class II/III devices?

Yes. CaseMark handles device listings across all FDA classification levels. For Class II and III devices, the output includes fields for 510(k) clearance numbers, predicate devices, and premarket submission references.

Is the output ready to submit directly to FURLS?

CaseMark produces a comprehensive draft structured for FDA submission via FURLS. However, all regulatory filings should be reviewed by your regulatory affairs team for accuracy and completeness before final submission.

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