Fda Device Registration

Draft FDA Device Registration Filings in Minutes

12 minutes with CaseMark

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12 minutes with CaseMark

What you'll need

Establishment Details
Device Inventory
Owner/Operator Information

SOC 2 Type II · HIPAA compliant · $5 free credit

Workflow

Overview

CaseMark's FDA Device Registration skill automates the drafting of Establishment Registration and Device Listing documents required under 21 CFR Part 807. It structures filings to mirror FDA Form 2830, organizing establishment details, owner/operator information, device inventories, compliance certifications, and signature blocks into submission-ready documents. Whether you're filing an initial registration, annual renewal, or foreign establishment listing, the AI handles the formatting and regulatory structure so your team can focus on accuracy and strategy.

Preparing FDA Establishment Registration and Device Listing documents is a tedious, detail-intensive process. Regulatory teams must manually structure filings to comply with 21 CFR Part 807, cross-reference device classifications and product codes, and ensure every field matches FDA Form 2830 requirements. Errors or omissions can delay registrations and trigger compliance issues.

CaseMark automates the drafting of 21 CFR Part 807 registration and device listing documents, structuring every section to mirror FDA Form 2830. By extracting and organizing your establishment details, device inventories, and owner/operator information into a submission-ready format, CaseMark eliminates manual formatting work and reduces the risk of filing errors.

How it works

1. Upload your establishment details, device inventory, and any prior registration documents
2. AI structures your filing to comply with 21 CFR Part 807 and FDA Form 2830 requirements
3. Review the generated registration document, verify device classifications and product codes
4. Export the completed filing in your preferred format (DOCX, PDF) for FURLS submission

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 structured establishment registration documents mirroring FDA Form 2830
Organizes device inventories with product codes, classifications, and 510(k) references
Supports initial registrations, annual renewals, listing updates, and foreign filings
Auto-formats US agent designations for foreign establishment compliance
Produces owner/operator sections with signature authority blocks
Validates business activity terms against FDA-recognized categories

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
List of devices including product codes, FDA classifications, intended uses, listing numbers, and 510(k) clearance numbers
.pdf, .docx, .xlsx, .csv
Owner/Operator Information
Legal names, titles, contact details, and signature authority designations for responsible parties
.pdf, .docx

Supporting documents

Prior Registration Documents
Previous FDA registration confirmations, listing numbers, or correspondence for renewal or update filings
.pdf, .docx
US Agent Designation Letter
US agent name, address, phone, and email for foreign establishment filings
.pdf, .docx
510(k) Clearance Letters
Existing 510(k) clearance documentation for devices requiring premarket notification 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 and FDA Form 2830 formatting requirements

Eliminate common filing errors with standardized device listing tables and FDA-recognized business activity terms

Streamline foreign establishment filings with automatic US agent designation sections

Questions

Does this tool generate documents compliant with current FDA requirements?

CaseMark structures your registration and device listing documents to mirror FDA Form 2830 and comply with 21 CFR Part 807. We recommend verifying the current form version at FDA.gov before submission, as FDA periodically updates requirements.

Can it handle foreign establishment registrations?

Yes. CaseMark automatically includes US agent designation sections when you indicate a foreign establishment filing. The output captures all required agent contact details and authorization language per FDA requirements.

What types of filings does this support?

CaseMark supports initial registrations, annual renewals, device listing updates, and foreign establishment filings. Simply indicate your filing type and the AI adapts the document structure accordingly.

How does it handle multiple devices in a single filing?

CaseMark generates a structured device listing table for each device, capturing product codes, FDA classifications (Class I, II, or III), intended use descriptions, 510(k) numbers, and predicate device references. There is no practical limit on the number of devices per filing.

Can I use this for 510(k) submissions?

This skill is specifically designed for establishment registration and device listing under 21 CFR Part 807, not for 510(k) premarket notification submissions. However, it does capture and reference existing 510(k) clearance numbers within your device listings.

How long does it take to generate a registration document?

CaseMark typically generates a complete registration and device listing document in approximately 10-15 minutes, depending on the number of devices and complexity of your establishment details. This replaces what traditionally takes hours or days of manual preparation.