Medical device manufacturers used to mail paper documents to FDA, and staff on both sides processed them by hand. An API-driven portal replaced that process 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.
- Paper made it hard to see where a submission was or to report on volumes and backlogs.
The solution
An API-driven portal that checks, cleans, and delivers every submission automatically.
Registration and identity
Manufacturers register in the portal, and the APIs check each organization and user before they can submit.
Security validation
Every call is authenticated and authorized. Submissions are checked for type, size, and completeness before they are accepted.
Virus checking
Every uploaded file is scanned for malware and quarantined if it fails. Nothing reaches agency systems until it passes.
Document-to-database conversion
Content is extracted from submitted documents into structured database records. 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 so teams can see problems early.
Results
Delivered in under a year
Built and put into service in less than 12 months, under close FDA oversight throughout.
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.
Visibility for managers
Tableau dashboards show volume, throughput, and exceptions as they happen.
Build the same pattern in the sandbox
The reference APIs in this portal follow the same design, so your team can prototype a submission portal today:
- Identity & Access API: registration, tokens, and scopes
- Document Services API: upload, scan, and text extraction
- Event streams: notify downstream systems when a document passes scanning
- Audit Log API: who submitted and accessed what
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Delivered by Iron Brick architects. The FDA name identifies the customer and does not imply endorsement.