For decades, laboratory developed tests (LDTs) have operated under minimal FDA oversight, but advancements in molecular biology, the rise of personalized medicine, and the critical role of diagnostic testing have prompted the FDA to revise its approach. In its recently announced phaseout policy, the FDA is moving toward full regulatory control of LDTs. By February…
Charles Chrisawn
Laboratory-developed tests (LDTs) have played a critical role in healthcare for decades, providing clinicians with diagnostic insights tailored to specific patient needs. Historically, these tests, developed and used within individual laboratories, have operated under the oversight of the Centers for Medicare and Medicaid Services (CMS) through the Clinical Laboratory Improvement Amendments (CLIA). The FDA, though…
In vitro diagnostics (IVDs) have become a cornerstone of modern medicine, and rising demand for these critical medical devices has driven rapid market growth. Since 2021, hospitals and laboratories have demonstrated an increasing preference for point-of-care testing devices to get accurate, real-time data. In addition, government organizations, associations, and agencies are encouraging the use of…
Laboratory developed tests (LDTs) and in vitro diagnostics (IVDs) play a critical role in modern medical care. According to the US Centers for Disease Control and Prevention (CDC), 14 billion laboratory tests are ordered each year and an estimated 70 percent of medical decisions are based on the results of these tests.1 Thus, diagnostic tests—and…
On April 29, 2024, the U.S. Food and Drug Administration (FDA) announced a final rule that was initially proposed in September 2023 concerning the regulatory framework for laboratory-developed tests (LDTs). Understanding the nuances and implications of these changes is paramount for specialists in regulatory affairs and the clinical development arena. The FDA updated its regulations…
On September 29, 2023, the U.S. Food and Drug Administration (FDA) made public a potentially game-changing proposal concerning the regulatory framework for laboratory-developed tests (LDTs).
Significant risk studies of medical devices require an investigational device exemption (IDE), which allows the device to be used in a clinical study to collect data on its safety and effectiveness.1 Often, device developers wonder whether—and how—the cost of those investigational devices might be covered not only to offset the cost of development, but also…
An investigational device exemption (IDE) allows an investigational device to be used in a clinical study to collect data on its safety and effectiveness.1 This exemption applies to the conduct of trials necessary for developing new medical devices. Most often, clinical studies are conducted to support a Premarket Approval (PMA) application, though some 510(k) submissions…
Development of liquid biopsies for early cancer detection requires careful planning. Understanding the regulatory environment and the challenges of conducting the studies needed for approval is integral to success. Here, we review the regulatory pathways for in vitro diagnostics (IVDs) in both the US and the EU and offer strategies for designing and operationalizing large-scale…
Cancer is the leading cause of death worldwide, accounting for nearly one in every six deaths. According to a recent paper, an estimated 15% of cancer-related deaths could be avoided by early disease detection.1 However, there are currently very few population-based screening programs and, even where a screening test does exist, compliance is relatively low….