Preparing FDA Establishment Registration and Device Listing documents manually requires hours of cross-referencing regulations, verifying classification codes, and ensuring compliance with 21 CFR Part 807. Attorneys must navigate complex FDA databases, validate product specifications against regulatory requirements, and format submissions according to strict agency standards—all while managing tight filing deadlines.
Preparing FDA Establishment Registration and Device Listing documents manually requires hours of cross-referencing regulations, verifying classification codes, and ensuring compliance with 21 CFR Part 807. Attorneys must navigate complex FDA databases, validate product specifications against regulatory requirements, and format submissions according to strict agency standards—all while managing tight filing deadlines.
CaseMark automates the entire FDA registration drafting process by intelligently extracting establishment and device information from your documents, cross-referencing current FDA regulations and classification databases, and generating compliant submissions formatted to agency standards. What once took half a day now takes minutes, with built-in verification against official FDA guidelines and templates.
This workflow is applicable across multiple practice areas and use cases
Healthcare law attorneys advising medical device manufacturers, hospitals, and healthcare facilities on FDA compliance requirements for medical devices and equipment registration.
Healthcare regulatory compliance heavily overlaps with FDA device registration, as healthcare facilities and manufacturers must navigate the same regulatory framework and documentation requirements.
Due diligence and regulatory compliance verification when acquiring or merging with medical device companies, ensuring all FDA registrations and device listings are current and compliant.
M&A transactions involving life sciences companies require thorough review of FDA compliance status, making automated registration document generation valuable for post-acquisition integration and compliance remediation.
Establishing new medical device companies or life sciences startups that need immediate FDA establishment registration and device listing as part of their initial regulatory compliance setup.
Corporate formation attorneys in the life sciences sector must ensure new medical device entities complete FDA registration requirements early in the formation process to legally manufacture or distribute devices.
Licensing agreements for medical device technology require verification of FDA registration status and ensuring licensees maintain proper device listings and establishment registrations.
IP licensing in the medical device space often includes regulatory compliance obligations, making FDA registration documentation essential for license agreements and ongoing compliance monitoring.
CaseMark cross-references your submission against current 21 CFR Part 807 regulations and official FDA templates like Form 2830. The platform validates device classifications, verifies required fields, and formats documents according to FDA standards, ensuring your registration meets all regulatory requirements.
You'll need establishment information (FEI number, business activities, owner details) and device specifications (product codes, classifications, intended use, listing numbers). CaseMark extracts this information from your uploaded documents and organizes it into the proper FDA format automatically.
Manual preparation typically takes 4-5 hours of attorney time to research regulations, verify classifications, and format submissions. CaseMark reduces this to approximately 12 minutes by automating data extraction, regulatory cross-referencing, and document generation.
Yes, CaseMark searches FDA device classification databases to verify product codes and classifications for your devices. The platform ensures each device listing includes accurate classification information and intended use descriptions that comply with FDA requirements.
Absolutely. CaseMark includes sections for U.S. agent details when applicable and incorporates any exemption documentation you provide. The platform ensures all compliance certifications and attestations meet FDA standards for both domestic and foreign establishments.
CaseMark uses intelligent document extraction to pull establishment details from your uploaded files, then validates this information against FDA registration format requirements. The platform flags missing or incomplete data and ensures all owner/operator details, contact information, and FEI numbers are properly documented.
You receive a complete, formatted document ready for attorney review and submission to the FDA. The document includes all required sections—from establishment information to device listings to signature attestations—with proper citations to applicable regulations and compliance certifications.