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.