FDA’s EUA for Covid LDTs Has Minimal Impact on Most LDTs
(Thursday, November 18, 2021)
This week FDA announced that it is going to require emergency use authorizations (EUA) for Lab Developed Tests (LDTs) intended for Covid diagnosis summarily reversing a decision last August that LDTs don’t need EUA. While this may seem like a major decision, it is not. The announcement is very specific to RT-PCR tests for Covid, and do not imply any policy changes for LDTs in general. LDTs currently do not require registration, formal clearance or approval by the FDA. LDTs form a very important and popular path for many sophisticated tests developed by labs that also offer them to patients through their doctors. During the early days of the pandemic in March-April 2020, FDA created an umbrella EUA to cover LDTs intended to diagnose Covid. About 27 labs with LDTs for Covid testing filed those EUAs. By most accounts there are several times more LDTs available to the patients by labs that did not file for the EUA. Since there is no formal (or even informal) list of LDTs, it is practically impossible for FDA to even know about these tests. So, for all practical intents and purposes, the EUA for Covid LDTs had little effect. Seeing that, in August of last year, about 4 months after the issue of the umbrella EUA for Covid LDTs, the Secretary of the Department of Health and Human Services (HHS) announced that since LDTs in general do not need EUA, Covid LDTs also do not need EUAs. The new announcement basically just reverses that policy that applied specifically to Covid LDTs, and also states that “HHS no longer has a policy on LDTs (for Covid) that is separate from FDA’s longstanding approach in this area”, which basically means that FDA reserves the right to ask LDT offerors to meet specific regulatory requirements on a case-by-case basis such as seeking an EUA for their Covid tests. The announcement does not mention the status of the LDTs that were created between the time of this announcement and August of last year. And without a formal list of LDTs, it is hard to imagine how FDA would enforce this policy for Covid LDTs since all LDTs are offered to the doctors directly by the labs without informing FDA. There are numerous widely available FDA authorized and cleared tests for Covid so LDTs probably play a small role anyway. But for anyone concerned about FDA suddenly changing its hands-off policy for LDTs, there is no reason to worry, at least for now. FDA has never shied to express its desire to see greater regulation of LDTs, but this latest announcement does not seem like a shot in that direction.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC