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..

印第安纳州卡梅尔，2024年5月3日/PRNewswire/--为了回应4月29日美国食品和药物管理局（FDA）最终规则21 CFR第809部分医疗器械：实验室开发测试（LDT），Orchard Software正在与其客户积极合作，以充分了解FDA监督LDT的含义和阶段。。

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..

FDA的裁决规定，包括LDT在内的体外诊断测试应视为联邦食品、药物和化妆品法案管辖下的医疗器械。作为实验室行业的技术领导者，Orchard Software意识到这一决定对实验室的影响，并打算保持在这一主题的前沿，利用其解决方案帮助实验室适应这些监管变化。。

'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.'.

Orchard Software首席执行官比利·怀特赫斯特（BillieWhitehurst）说：“实验室信息系统（LIS）是实验室运营与法规遵从性之间的重要桥梁，确保LDT遵守最高标准并为患者护理做出贡献。”在Orchard，我们意识到FDA裁决对我们实验室客户的影响，并打算利用和改进我们的技术，通过这一变化为他们提供支持。”。

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..

LIS在支持LDT的新法规方面起着至关重要的作用。Orchard的解决方案是根据监管要求构建的，旨在跟踪和支持实验室的质量管理系统、标准化工作流程以及互操作性和分析需求。有了这个功能，LIS可以成为一个巨大的工具，帮助实验室解决这些重要的新需求。。

About Orchard Software CorporationOrchard 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.

关于Orchard Software Corporation Orchard Software Corporation是实验室信息系统行业的领导者，提供多种解决方案。Orchard为全国2000多个实验室提供服务，帮助他们提高效率，减少错误，加强整合。Orchard基于云的解决方案安装在医生团体和诊所、医院、独立参考实验室、学生健康中心、兽医实验室、公共卫生组织、大学和零售设施中。

For more information regarding Orchard Software Corporation, visit www.orchardsoft.com..

有关Orchard Software Corporation的更多信息，请访问www.orchardsoft.com。。

Media Contact:Steve Hurwitz, Vice President of Marketing(800) 856-1948 | shurwitz@orchardsoft.com

媒体联系人：Steve Hurwitz，营销副总裁（800）856-1948 |shurwitz@orchardsoft.com

SOURCE Orchard Software Corporation

SOURCE Orchard软件公司