HHS Clarifies that FDA Cannot Regulate LDTs
[Thursday, August 27, 2020] The Department of Health and Human Services (HHS), the governing body over the FDA, rescinded FDA’s guidance documents regarding the need for pre-market approval or emergency use authorization for Laboratory Developed diagnostic tests (LDTs). LDTs are widely used and have been in a regulatory limbo for many years because of contradictory FDA announcements. FDA has repeatedly claimed that it can require formal premarket review of LDTs and that LDTs ought to be treated like conventional diagnostics, while at the same time allowing LDTs to be widely available under its policy of enforcement discretion. This week, HHS explicitly clarified the regulatory policy. The HHS specifically instructed FDA to create rules through the formal rule making process, as “opposed to through guidance documents, compliance manuals, website statements or other informal issuances”, if the FDA believes LDTs should require premarket approval or clearance. Now FDA will either need to let this issue stay as is or go through a long rule making process which involves public participation. In the past, FDA’s proposals to regulate LDTs were met with stiff public opposition. LDTs are an enigma; on one hand they provide an opportunity for small labs to commercialize diagnostic tests via doctor’s offices without having to go through expensive regulatory approvals, and on the other hand, they allow scrupulous players to peddle dubious and poorly validated diagnostics that may or may not benefit the patients. But now the regulatory policy should be clear; if you have an LDT for any disease, you can use it without fearing FDA changing its policy randomly without warning. At the same time, it may push the hardliners at FDA to go forward with the rule making process formally closing the LDT pathway for good. Either way, we have clarity on policy, which is a rare feat for such controversial issues. |
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