The U.S. Food and Drug Administration (FDA) issued today a Discussion Paper on Laboratory Tests (LDTs). The Discussion Paper follows draft guidance issued by the FDA in 2014 (2014 Draft Guidance) and a stakeholder workshop held in 2015 regarding the oversight of LDTs. The Discussion Paper does not represent final guidance. Rather, the Discussion Paper is the FDA’s “synthesis of all feedback” received, which the FDA hopes will “advance public discussion on future LDT oversight.” The Discussion Paper is not enforceable.
The FDA explains in the Discussion Paper that there is growing consensus that additional oversight of LDTs is necessary. The FDA’s proposal would include exempting LDTs already on the market from FDA oversight except for adverse event and malfunction reporting; exempting traditional LDTs and LDTs for public health surveillance from all oversight; providing additional time before FDA begins actively overseeing certain regulatory requirements; and shortening the overall phased-in timeframe to four years rather than the nine years originally proposed by the FDA in the 2014 Draft Guidance.
Additionally, the FDA suggests that its prospective oversight would focus on new and significantly modified moderate and high risk LDTs. FDA generally would not focus oversight efforts on low risk LDTs; LDTs for rare diseases; traditional LDTs; LDTs intended solely for public health surveillance; LDTs used in CLIA-certified, high-complexity histocompatibility labs for certain testing in connection with organ, stem cell and tissue transplantation; and LDTs intended solely for forensic use. Further, the FDA proposes more flexibility for new LDTs that address unmet needs in order to promote innovation and patient access to new scientific findings.
The FDA also stated that its premarket review would be complementary to, and not duplicative of, CMS’ postmarket oversight of laboratory operations and clinical utility determinations. Additionally, the FDA would increase the use of third parties, including expanding its third party premarket review program and third party inspection program.
The concept of transparency was highlighted by the FDA in the Discussion Paper, stating that evidence of the analytical and clinical validity of all LDTs should be made publicly available. The FDA stated that it should publish its review memorandum for tests reviewed by the FDA and laboratories should publish this information for tests not reviewed by the FDA.
Companies with current LDTs or who are developing LDTs should carefully review and analyze the Discussion Paper. Companies also should continue to evaluate guidance issued by the FDA regarding the oversight of LDTs, and maximize opportunities to provide comments to such guidance.