How USDM Helped Expedite a 510(k) and Win FDA Clearance Ahead of Deadline
A medical device software company built a next-generation Blood Establishment Computer Software (BECS) platform to support safe, efficient, and compliant regulated blood supply chain management, and needed FDA clearance of its 510(k) on a tight timeline. There is a long list of global regulations that govern these submissions, and USDM has the experience and expertise to support life sciences companies with their domestic and global filings.
The Challenge
The manufacturer of this FDA-regulated medical device faced a tight 510(k) submission deadline and needed expert help creating the body of the 510(k) itself. The submission depended on a large set of supporting documentation that had to be reviewed and validated, and the customer wanted to reach FDA clearance with as few questions as possible.
- Manufacturer of an FDA 510(k) medical device on a compressed submission timeline.
- More than 100 supporting documents required review before submission.
- The customer needed clearance from the FDA with minimal questions.
For a BECS platform underpinning the national blood supply, the integrity of every supporting record matters. Strong data integrity in life sciences and adherence to 21 CFR Part 11 compliance were essential to a defensible submission.
The Approach
USDM partnered directly with the client's quality assurance (QA) and regulatory affairs (RA) managers to move quickly without compromising rigor.
- USDM reviewed more than 100 supporting documents for the submission, then drafted the body of the 510(k).
- USDM worked hand-in-hand with the QA and RA teams to validate supporting documentation and align the submission package.
- The team applied a risk-based, computer software assurance (CSA) mindset to focus effort where it mattered most for software-driven medical devices.
This approach is part of USDM's broader continuous compliance practice, which keeps regulated software and its evidence audit-ready from submission through ongoing operation.
The Results
FDA clearance was received weeks ahead of the customer's deadline, with minimal questions back from the agency.
- More than 100 documents reviewed.
- 80 man-hours saved for the client's internal teams.
- Clearance received weeks before the due date.
- Minimal questions from the FDA.
“Through a combination of expertise, experience, and excellent customer service, USDM provided the tools we needed to submit for our 510(k) and receive clearance ahead of our schedule.”
–Adam Rosenzweig, General Manager, ARC-One
About ARC-One
ARC-One Solutions, LLC was created in April 2020 through a partnership between two of the largest blood centers in the country, the American Red Cross and OneBlood. ARC-One Solutions has the privilege and responsibility to assist these organizations in fulfilling over 50% of the nation's blood supply needs. Once implemented, their software will process approximately 10 million products across 56 states and territories.
By clearing the FDA weeks early and with minimal questions, USDM helped get a mission-critical blood supply platform to market faster. To accelerate your next regulated submission with the same rigor, talk to a USDM regulatory expert.