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.