HHS directs the FDA to ease off regulating LDTs in the middle of a pandemic w/
Stunning HHS decision to drop FDA pre-market review of lab-developed COVID19 tests. The issue is complex. But this isn't necessarily bad.
BREAKING: HHS is directing FDA to not require premarket review of laboratory developed tests - an action public health experts tell and I could allow lower quality #COVID19 tests onto the market in the middle of the pandemic
Following my/'s story last night on HHS' new policy directing FDA to not conduct premarket review of lab developed tests, House Energy and Commerce Chair is requesting brief the committee on the change.
Odd to see HHS claiming in this new fact sheet I obtained that FDA only enforced against lab-developed tests during public health emergencies. For example, FDA sent a warning letter in 2019 to Inova Genomics Laboratory.
The Trump administration will allow #COVID19 tests developed by commercial laboratories to be used without an FDA review, a decision that public health experts warn could lead to broad use of flawed tests. via
"2 senior admin officials told POLITICO that the new HHS policy is not specifically aimed at relaxing rules for coronavirus testing. Instead..it is based on HHS's determination that FDA does not have the authority to regulate LDTs for any condition.."
This appears to be a pretty massive change in FDA policy around how COVID-19 lab-developed tests will be regulated going forward.
Trump administration limits review of some #coronavirus tests: The policy change has been a major point of tension for weeks between and FDA. via &
This is fascinating & potentially a really bad idea - FDA can’t regulate COVID19 tests anymore, the tests’ claims, etc. EUAs just lost most of their teeth Interesting precedents being set during this pandemic for post-COVID Dx/Tx dev
Question - does this ruling mean that the quick & inexpensive COVID tests developed in labs at Columbia, Harvard, Rutgers and other universities can be disseminated and used without FDA approval?