Orchard Software's Solutions Provide Support for Labs That Perform LDTs, Now Under FDA Oversight

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The FDA ruling mandates that in vitro diagnostic tests, including LDTs, be considered medical devices under the Federal Food, Drug & Cosmetic Act jurisdiction.

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Provider:

PR Newswire

Retrieved on:

星期五, 五月 3, 2024

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Tags:

FDA, Health, Medical device, CFR, Orchard, Laboratory, LIS, Food and Drug Administration

Geotags:

INDIANA

⚠ partially generated by AI ↴

摘要

Key Points:

The FDA ruling mandates that in vitro diagnostic tests, including LDTs, be considered medical devices under the Federal Food, Drug & Cosmetic Act jurisdiction.
"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."
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.

Orchard Software's Solutions Provide Support for Labs That Perform LDTs, Now Under FDA Oversight

CARMEL, Ind., May 3, 2024 /PRNewswire/ -- In response to the April 29^thU.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 | [email protected]

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SOURCE Orchard Software Corporation