Right now the FDA is trying to bring lab developed tests (LDTs) under FDA regulation, and their list of reasons is a bunch of anecdata, nothing like 500 deaths.

Right now the FDA is trying to bring lab developed tests (LDTs) under FDA regulation, and their list of reasons is a bunch of anecdata, nothing like 500 deaths. FDA does not provide evidence that they will provide better controls or improved safety, just that there were very minor reports from LDTs. CPAP machines were reclassified to class II devices in 2018, which requires that companies perform QMS and tell the FDA, and sometimes get audited. LDTs require Lab Directors to take responsibility for the quality of a test at the risk of their license. Auditing is performed by professional societies, to high level. Public health labs and hospitals are furious about the extra, unnecessary paperwork that FDA taking this action would cause, for no apparent benefit. The FDA allowing more than 500 deaths to happen is a massive indictment of their quality of auditing, and should signal that if they take over LDT regulation, more lives will be at risk.