In a significant decision that is likely to garner a vast interest from clinical laboratories and medical device manufacturers, the U.S. Food and Drug Administration (FDA) has introduced a controversial proposed rule on September 29. If enacted, this rule stands to monumentally modify the existing regulatory framework for laboratory developed tests (LDTs).
The FDA has historically treated LDTs as medical devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The core aim of the proposed rule is to further bolster the FDA’s authority over LDTs, thereby ensuring that they comply with the provisions of the FD&C Act as deemed appropriate by the agency.
Currently, there is an ongoing debate over the extent of the FDA’s authority over LDTs. Critics argue that the FDA may be overexerting their authority by regulating this realm of the industry that is, by and large, under the auspices of the Centers for Medicare & Medicaid Services (CMS). Nevertheless, the FDA contends that its power to regulate falls within its statutory authority.
The proposed rule, if passed, will have a tremendous impact on the industry as it stands to drastically change the way LDTs are developed and regulated. It is a critical issue that industry professionals need to closely observe as it can considerably shape their operations going forward.
For more detailed information, you can read more about it on this article by Nelson Mullins Riley & Scarborough LLP on JDSupra.