FDA and CMS issued a joint statement affirming FDA's authority to regulate LDTs. This comes at an interesting timing, after the industry submitted many comments re: FDA's proposed rules on LDTs, issued in Sept. 2023. The agencies make it very clear that expanding CLIA regarding LDTs "makes no sense," and that CLIA "is separate in scope and purpose from FDA oversight." If you recall, it was just 3.5 years ago in Aug. 2020 that HHS revoked FDA's authority to regulate LDTs. HHS then reversed this in 2021 and now, the agencies make it very clear that FDA can regulate LDTs.
Policies that change so frequently can be confusing for the industry, and it is difficult for the industry to know what to follow and how. It would be helpful for the agencies to engage in in-depth discussions with the industry, then propose a direction and policies that the stakeholders can rely on and comply with.
https://lnkd.in/egp_3sM4
"Some have suggested that concerns with LDTs should be addressed through expansion of CLIA. This is not the answer. As was stated in our 2015 testimony, CMS does not have the expertise to assure that tests work; the FDA does. Moreover, establishing a duplicative system for the oversight of tests by expanding CLIA would create more government bureaucracy and inconsistencies. That makes no sense." (emphasis added)
"[W]e are – together – reiterating that CMS’s CLIA program is separate in scope and purpose from FDA oversight." (emphasis added)
Vice President, Regulatory Affairs @ HDA
2moGreat job folks!