As you are likely aware, the U.S. Food & Drug Administration (FDA) recently ruled that Laboratory Developed Tests (LDTs) as in vitro diagnostic products (IVDs) are devices that fall under the Federal Food, Drug, and Cosmetic Act (FD&C Act), including when the manufacturer of the IVD is a laboratory (Final Rule).¹ This decision was made due to a growing concern that LDTs are becoming more complex. Congressional leaders have expressed disappointment in the FDA rule, including its potential impact on access to diagnostic and medical tests and the costs of these tests. The FDA’s ruling will lead to greater oversight of LDTs starting with a four-year phaseout of its general LDT enforcement, plus targeted enforcement policies for certain categories of IVDs manufactured by laboratories.²

FDA Ruling’s Impact on Laboratories

At Orchard, we understand the importance of LDTs within the laboratory, and we understand the broad impact the FDA’s ruling will have on labs across the country. This is a significant change for many laboratories, and we are here to offer our support.

Your laboratory information system (LIS) plays a crucial role in maintaining compliance with the new LDT rules. Orchard’s solutions are built with regulatory requirements in mind and designed to track and support the laboratory’s quality management activities. There are myriad ways that your LIS can help support you through this change. Orchard’s solutions can be used by those labs that chose to apply for FDA clearance on their LDTs.

SOPs for FDA LDT Test Development

Specifically, labs can use Orchard’s products, including our enterprise workflow engine, to prove that they have implemented standardized and reproducible operating procedures and workflows.

Analytics, QC, & Regulatory Compliance

Orchard’s solutions can be used to track and comply with the post-FDA clearance process including adverse event reporting and ongoing validation of the FDA cleared assays. 

Efficiency & Productivity

Orchard’s solutions enable clients to increase their efficiency and productivity, which will become increasingly important as the FDA ruling is implemented. 

Interoperability & Connectivity

Orchard Software is an expert at integration, meaning your LIS can communicate seamlessly with other systems, such as EHRs. Integrated into a larger interoperable organization, your LIS provides data sharing, reduces errors, and speeds test reporting.

FDA Webinar Opportunity

The FDA plans to grandfather in LDTs that were on the market before the final ruling. They are planning an overview webinar on May 14, 2024 to discuss the final rule and phaseout policy.

Orchard is Here to Help

In summary, your 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. If you have questions about how your LIS can help your lab meet the new requirements, contact your Orchard Account Manager for guidance.

Read our blog post for more information about the ruling.

References

1. U.S. Food & Drug Administration. FDA Takes Action Aimed at Helping to Ensure the Safety and Effectiveness of Laboratory Developed Tests. Accessed at: www.fda.gov/news-events/press-announcements/fda-takes-action-aimed-helping-ensure-safety-and-effectiveness-laboratory-developed-tests
2. U.S. Food & Drug Administration. Laboratory Developed Tests. Accessed at: www.fda.gov/medical-devices/in-vitro-diagnostics/laboratory-developed-tests