On October 7, FDA announced it wouldn't review LDTs for EUA status, and the House E&C committee sent a six page letter to Alex Azar at HHS about his recent decisions regarding FDA and LDTs.
Stories cited back to an October 2 Politico article that unveiled a June 2020 17-page legal memo, by HHS, arguing that FDA didn't have authority to review LDTs.
See my blog here:
http://www.discoveriesinhealthpolicy.com/2020/10/legislators-say-hhs-decision-to-remove.html
I've put six documents together in one cloud zip file, here:
https://drive.google.com/file/d/1m7oZjcgBu6YuLzYOFWQXztBKTVEuBTpO/view?usp=sharing
2020 MHC 1007 New News re Hill Letters to Azar re LDT.pdf
2020 HILL 1007 Energy and Commerce to Azar re LDT FDA 6p.pdf
2020 HILL 1007 Press Release re Letter to Azar on LDT.pdf
2020 Politico 1002 Re June Legal Memo HHS to FDA Nix LDT Review.pdf
2020 HHS 0622 Legal Memo to End FDA Review of LDTs 17pp.pdf
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