Overview
Medical device manufacturers mailed paper documents to FDA, and staff on both sides processed them by hand. An API-driven portal replaced that with secure electronic submission, automated checks, and data that supports near real-time audits and device updates. It was delivered in less than a year under close agency oversight.
The challenge
- Manufacturers prepared physical documents and shipped them to FDA by FedEx.
- FDA staff received, logged, and keyed the contents by hand before review could start.
- The process was expensive and labor-intensive for manufacturers and the agency alike, and slow shipping and manual entry delayed audits and device record updates.
| Customer | U.S. Food and Drug Administration |
|---|---|
| Users | Medical device manufacturers and FDA staff |
| Timeline | Under 12 months, with close agency oversight |
| What changed | Paper shipped by FedEx and manual entry replaced by secure electronic submission |
The Solution
Registration and identity
Manufacturers register in the portal, and each organization and user is checked before they can submit.
Security validation
Every call is authenticated and authorized, and submissions are checked before they are accepted.
Virus checking
Every uploaded file is scanned for malware. Nothing reaches agency systems until it passes.
Document-to-database conversion
Content is extracted into structured database records, so reviewers work with data instead of rekeying it.
System-to-system APIs
Clean records flow to FDA systems through governed APIs, so audits and device updates use current information.
Monitoring in Tableau
Dashboards track submission volumes, processing times, failures, and backlogs.
Results
Delivered in under a year
Built and put into service in less than 12 months, under close FDA oversight.
Paper and courier steps removed
Electronic submission replaced physical documents shipped by FedEx.
Manual work cut on both sides
Automated validation, scanning, and conversion replaced hand logging and data entry.
Near real-time oversight
Structured data supports near real-time audits and medical device updates.
Engagements delivered by Iron Brick architects, directly and as part of prime contractor and platform partner teams. Agency names identify the customer and do not imply endorsement.
Facing a similar challenge?
We can walk through how this approach would apply to your systems.