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510(k) Approval Weeks Ahead of Deadline


Learn how USDM helped expedite the creation of a 510(k) and received FDA approval on the submission.

ARC-One Solutions created a next-generation Blood Establishment Computer Software (BECS) platform to support safe, efficient, and compliant regulated blood supply chain management and required FDA approval of their 510(k).

There is a long list of global regulations and USDM has the experience and expertise to support life sciences companies with their domestic and global submissions.

The Situation
  • ARC-One Solutions, LLC
  • Manufacturer of an FDA 510(k) cleared medical device
  • The customer had a tight 510(k) submission deadline and needed assistance creating the 510(k) body
  • Review of supporting documentation required for the submission
  • The customer wanted to receive clearance from the FDA with minimal questions
The Solution
  • USDM worked with the quality assurance (QA) and regulatory affairs (RA) managers, and the
  • USDM reviewed more than 100 supporting documents for the submission, then drafted the body of the 510(k)
  • FDA clearance was received weeks ahead of customer’s deadline

The Results

  • More than 100 documents reviewed
  • 80 man-hours saved
  • Clearance received weeks before due date​
  • Minimal questions from 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.

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