FDA Gap Analysis for FLOXbr device

The University of Virginia awarded a contract to North American Science Associates (NAMSA) on July 18, 2026, for regulatory compliance services related to the FLOXbr medical device. The contract encompasses Food and Drug Administration (FDA) gap analysis services with a cumulative value of $14,222.50. The line item specifies delivery of 14,222 units at a unit price of $1.00 each, though the actual deliverable represents a gap analysis assessment rather than tangible units in the traditional sense.

This Virginia-based contract award reflects the University of Virginia's engagement of specialized consulting expertise to support product development and regulatory strategy for the FLOXbr device. NAMSA, the prime contractor, will conduct the FDA gap analysis to identify compliance deficiencies and regulatory requirements necessary for device approval or clearance. While specific performance locations are not detailed in the award documentation, the contracting organization is the University of Virginia. The relatively modest contract value and focused scope indicate a discrete, time-limited analytical engagement rather than an extensive research or development program.