In August 2020, the Trump administration issued a policy restricting FDA from reviewing LDTs. (The August policy was based in part in a lengthy internal legal memo on FDA review of LDTs a few months earlier).
On November 15, HHS officially withdrew the August 2020 policy.
LDTs IN GENERAL
The HHS statement might have been accelerated in part by a recent October position at PEW on the dangers of unregulated LDTs (my blog here).
FDA & COVID & EUA
From a few days ago, HHS to invest $650M for POCT/PCR/COVID.
See my August 20, 2020 story on the original HHS decision here. Also in 2020: See a September 2 story here at DIHP about "dueling FDA and HHS announcements," here. See an October 7 story here at DIHP about Congressional kickback regarding the need to reign in LDTs here. The August 20, 2020 HHS notice blocking LDT review was based on an earlier, June 22 17 page legal memo on the topic, here.
FDA and CMS "high throughput" rules differ.
I noticed that FDA defines "high throughput technologies" in the guidance above, differently than CMS defines "high throughput technologies" for the purpose of increased COVID payment under CMS codes U0003, U0004. In the FDA guidance, here, they focus on high throughput technologies defined as 2, 384-well plates per 8 hours. (768 per 8 hours or 2304 per 24 hours). In the CMS guidance in April 2020, introducing new codes priced at 2X of conventional PCR Covid ($100 instead of $50), CMS defined "high throughput" as 200 cases per day. Here.