Executive Summary - March 2015
Update on LDT Framework, After Public Comment Period Closes
Maureen Bennett (Jones Day, Boston, MA and San Francisco, CA) and Colleen M. Heisey, Brigid C. DeCoursey, and Laurie A. Clarke (Jones Day, Washington, DC)
On September 30, 2014, the U.S. Food and Drug Administration (FDA) released the two draft guidance documents setting forth FDA's proposed framework for regulating Laboratory Developed Tests (LDTs) as medical devices: (1) Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories: Framework for Oversight of Laboratory Developed Tests (LDTs) (draft Framework); and (2) Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories: FDA Notification and Medical Device Reporting for Laboratory Developed Test (LDTs) (draft Notification Guidance). As described by FDA, an LDT is a type of in-vitro diagnostic test that is intended for clinical use and designed, manufactured, and used within a single laboratory. LDTs do not include devices designed or manufactured completely, or partly, outside of the laboratory that offers and uses them. LDTs were formerly called "home brews" and/or "in-house devices." However, the draft Framework and draft Notification Guidance apply to products marketed as LDTs, regardless of whether the products meet the definition, except for direct-to-consumer products. FDA intends to end its policy of enforcement discretion toward LDTs gradually over the next decade, but it will not regulate LDTs unless or until at least one of the draft guidance documents is finalized.
Before the comment period on those guidances closed on February 2, 2015, FDA held a public workshop regarding the draft guidances. Most public statements at the workshop and comments submitted to the docket have been critical of FDA's proposal for ending its policy of enforcement discretion toward LDTs, but some commenters acknowledged the need for additional regulation via Clinical Laboratory Improvement Amendments. Despite the wide range of public opinions on FDA's proposed approach to regulating LDTs, FDA still seems intent on regulating them. It is unclear whether FDA will make significant changes to the proposed approach in light of the public comments and, if so, whether FDA will publish a revised draft of one or both of the draft LDT guidances as several commenters requested. It is also unclear whether Congress will step in and decide whether, and if so, to what extent, FDA will regulate LDTs as devices and/or require notice-and-comment rulemaking. So, uncertainty regarding the regulation of LDTs will persist, at least for the near future.
We would like to thank the authors for sharing their expertise with their colleagues.