Small Group of Labs, Dx Manufacturers Float Alternative to FDA LDT Guidance

FDA recently issued draft guidance documents on its proposed regulation of laboratory developed test (LDTs). The guidance documents set forth the FDA’s plan to regulate LDTs using existing medical device regulatory systems. FDA has asserted that such regulation is necessary to ensure that such tests are safe and effective. FDA asserts that it may now regulate LDTs because the circumstances surrounding the conduct of LDTs and the tests themselves have changed since FDA initially decided to exercise its enforcement discretion over such tests. Whether, and to what extent, LDTs should be regulated by the FDA has been a subject of great debate. Many clinical laboratories maintain that LDTs should not be regulated by FDA. Others, however, express concern that LDTs, such as certain genetic tests for disease risk, may be marketed to consumers without adequate oversight or assurance of clinical validity. A small group of labs and test manufacturers has taken a shot at coming up with its own proposal for regulating so-called in vitro clinical tests that it hopes will be an acceptable compromise for industry players that often disagree on the regulation of laboratory-developed tests (LDTs). The new proposal by the so-called Diagnostic Test Working Group (DTWG), available here, tries to address these concerns and align regulations closer to real-world practice. Their plan creates a new category for the in vitro clinical test (IVCT), which would comprise both test kits and platforms, as well as laboratory test protocols. IVCTs would be a new category under the US Federal Food, Drug, and Cosmetic Act and wouldn’t be overseen as devices, drugs, or biologics, according to a draft of the plan. Depending on a lab’s or manufacturer’s activities, regulation would be spread over CMS, the FDA, and the states.

Source: https://www.genomeweb.com