CARMEL,
Ind., May 3, 2024 /PRNewswire/ -- In
response to the April
29th U.S. Food & Drug Administration (FDA)
Final Rule 21 CFR Part 809 Medical Devices: Laboratory Developed
Tests (LDTs), Orchard Software is actively working alongside its
customers to fully understand the implications and phases of FDA
oversight of LDTs.
The FDA ruling mandates that in vitro diagnostic tests,
including LDTs, be considered medical devices under the Federal
Food, Drug & Cosmetic Act jurisdiction. As a technology leader
within the laboratory industry, Orchard Software is aware of the
impact of this decision on laboratories and intends to remain at
the forefront of this topic, leveraging its solutions to help
laboratories adapt to these regulatory changes.
"The laboratory information system (LIS) serves as a critical
bridge between laboratory operations and regulatory compliance,
ensuring that LDTs adhere to the highest standards and contribute
to patient care," said Billie
Whitehurst, CEO of Orchard Software. "At Orchard, we realize
the impact of the FDA ruling on our laboratory customers and intend
to leverage and advance our technology to support them through this
change."
The LIS plays a crucial role in supporting the new regulation
for LDTs. Orchard's solutions are built with regulatory
requirements in mind and designed to track and support the
laboratory's quality management systems, standardized workflows, as
well as interoperability and analytics needs. With this
functionality, the LIS can be a tremendous tool to help labs
address these significant, new requirements.
About Orchard Software Corporation
Orchard Software
Corporation is a leader in the laboratory information system
industry and offers a variety of solutions. Orchard serves more
than 2,000 laboratories across the country, helping them improve
efficiency, reduce errors, and enhance integration. Orchard's
cloud-based solutions are installed in physician groups and
clinics, hospitals, independent reference labs, student health
centers, veterinary labs, public health organizations,
universities, and retail facilities. For more information regarding
Orchard Software Corporation, visit www.orchardsoft.com.
Media Contact:
Steve
Hurwitz, Vice President of Marketing
(800) 856-1948 | shurwitz@orchardsoft.com
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SOURCE Orchard Software Corporation