In mid-August, HHS abruptly announced that FDA was blocked (by HHS) from reviewing LDTs. (See entry point and links here).
Letters from House to HHS
On October 7, several legislators in the House released a public condemnation of this decision, via a press release and via a public letter to HHS Secretary Alex Azar. See the six-page public letter here. The press release is clipped below the break.
More: FDA Stops EUA Review for Local LDTs
Also on October 7, FDA announced that it would not review LDTs for COVID EUA status - here.
This latter FDA move is important because some COVID testing laws for commercial insurers and payments depend on whether tests have been FDA-reviewed (e.g. cleared, approved, or EUA). See page 3-4 at this HHS PDF here.
Regarding FDA stopping LDT review for EUAs, articles here and here. It's been suggested that FDA wants to prioritize review of POCT and high-throughput IVD tests, rather than local LDT tests. "To make the best use of our resources for the greatest public health benefit, FDA is declining to review EUA requests for LDTs at this time," stated OIVD director Tim Stenzl. "We are currently in a different phase of the pandemic with respect to tests than we were previously," he added.
Back Story: HHS Memo to End LDT Review
The House letter cites an October 2 Politico story that revealed a 17-page legal memo drafted at HHS that undercut FDA's arguments it had statutory authority to review LDTs in the first place. Politico here, PDF of memo released here. (24 mb). The legal memo dates to June 22. It amounts to a master class in FDA history regarding LDTs, written toward the endpoint that FDA can't regulate LDTs.
There is also a "two-pager" FAQ at HHS about the recent changes in FDA and LDT policy (here). The FAQ notes (its last question) that FDA review is required to get certain legal benefits for COVID tests.