← All workflows

Fda Device Registration

Draft FDA Device Registration Filings in Minutes

12 minutes with CaseMark

Fast lane

We have it from here.

Choose the fast one-off run here, or jump into the workspace when you want saved history, revisions, and a fuller matter workflow.

Run this once here

Best for a quick one-off job. Add your email, upload the files, and we'll run the workflow and send the result to your inbox.

1. Add your email so we know where to send the result.

2. Upload the files you want analyzed.

3. Run the workflow and we'll take it from there.

Use in Workspace

Best for ongoing matters

Save and reopen matters, keep documents together, refine the output, rerun with changes, and export or share polished work product when you're done.

Open in Workspace

Need more context?

Scroll for the workflow details below if you want to review what this run handles, what documents help, and what the output looks like.

If this is part of a live matter, the workspace is the better fit: you can keep your documents together, revisit the result, and keep working without starting from scratch.

Jump to detailsOpen in Workspace

Start here

Run this workflow now

Best for a fast one-off run. Add your email, upload the files, and we'll deliver the result without sending you into the full app.

Workflow

Fda Device Registration

Step 1 · Deliver to

Step 3 · Run this workflow

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 structures complete filing packages—including establishment details, owner/operator information, device inventories, compliance certifications, and signature blocks—mirroring FDA Form 2830 for streamlined submission through FURLS.

Preparing FDA Establishment Registration and Device Listing documents is a tedious, detail-intensive process that demands precise compliance with 21 CFR Part 807. Regulatory teams spend hours manually compiling establishment data, cross-referencing device classifications and product codes, and formatting filings to match FDA Form 2830—with costly errors often discovered only after submission.

CaseMark automates the entire drafting workflow by ingesting your establishment details, device inventory, and owner/operator records, then generating a fully structured registration package that mirrors FDA Form 2830. The AI ensures every required field is populated, business activity terms match FDA-recognized categories, and device listings include proper classification and clearance references—delivering submission-ready documents in a fraction of the time.

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 document, device listings, and compliance certifications

  4. 4. Export the finalized filing package in your preferred format (DOCX, PDF)

What you get

  • Document Header with Filing Type and Regulatory Basis

  • Establishment Information with FEI and Business Activities

  • Owner/Operator Details with Signature Authority

  • Device Listing Table with Product Codes and Classifications

  • US Agent Designation (Foreign Establishments)

  • Compliance Certifications and 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 certifications and attestation blocks ready for execution

Required documents

  • Establishment Details

    Corporate records including legal name, FEI number, physical and mailing addresses, and business activities

    .pdf, .docx, .xlsx

  • Device Inventory

    Complete device records with product codes, classifications, intended uses, listing numbers, and 510(k) references

    .pdf, .docx, .xlsx, .csv

  • Owner/Operator Information

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

    .pdf, .docx

Supporting documents

  • US Agent Designation

    US agent name, address, phone, and email for foreign establishment filings

    .pdf, .docx

  • Prior Registration Records

    Previous registration numbers, listing numbers, and any pending premarket submissions

    .pdf, .docx

  • 510(k) Clearance Letters

    FDA clearance documentation for devices requiring predicate device references

    .pdf

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 requirements and FDA Form 2830 formatting

Eliminate common filing errors by auto-validating required fields, product codes, and classification data

Maintain a consistent, audit-ready format across initial registrations, renewals, and listing updates

Questions

Does this handle both domestic and foreign establishment registrations?

Yes. CaseMark automatically includes US agent designation sections when processing foreign establishment filings. The AI recognizes the filing context and structures the document accordingly with all required foreign manufacturer fields.

How does CaseMark ensure compliance with 21 CFR Part 807?

CaseMark structures every output to mirror FDA Form 2830 and uses only FDA-recognized business activity terms, product code formats, and classification categories. The AI cross-references your device data against required fields to flag any gaps before you finalize.

Can I use this for annual renewal filings?

Absolutely. CaseMark supports initial registrations, annual renewals, and listing updates. Simply indicate the filing type and upload your current establishment and device records, and the AI will generate the appropriate renewal documentation.

Does the output include 510(k) and predicate device references?

Yes. For each listed device, CaseMark captures 510(k) clearance numbers, predicate device information, and premarket submission details when applicable. This ensures your device listing is complete and audit-ready.

How long does it take to generate a complete registration package?

CaseMark typically generates a full FDA establishment registration and device listing document in approximately 12 minutes, compared to the hours or days it traditionally takes to compile these filings manually.

Can I edit the generated document before submission?

Yes. CaseMark produces a fully editable document that you can review, customize, and refine before submitting through FURLS or other FDA submission channels. The output is designed as a drafting accelerator, not a replacement for regulatory review.

Related

510k Premarket Notification

Draft FDA 510(k) Submissions in Minutes, Not Weeks

Adverse Event Reporting Policy

Draft FDA-Compliant Adverse Event Policies in Minutes

Aml Compliance Program

Draft Board-Ready AML Compliance Programs in Minutes