Lawmakers Issue Dx Reform Bill To Strike Regulatory Balance
Executive Summary
After failing to gain traction last year, a couple of US lawmakers are hoping to garner support for a pair of bills that would require certain diagnostic tests to be regulated by the US FDA that are currently outside the scope of the agency’s oversight. The bills are intended to be a solution to concerns that certain tests do not require adequate proof of safety and effectiveness, which could lead to misdiagnoses.
You may also be interested in...
FAQ Sheet From HHS Says FDA ‘Rarely Enforced’ Premarket Review Of LDTs
The US HHS defends its recent decision to relieve the FDA from oversight of laboratory developed tests in a new FAQ sheet, saying the agency hardly ever enforced the premarket review of LDTs in the first place.
Legal Experts: HHS Policy Change Strips FDA Of Oversight For All LDTs
Three lawyers tell Medtech Insight that the recent move by the US HHS to revoke the FDA’s authority to oversee laboratory developed tests extends to all LDTs, and not just those used to test for COVID-19.
Ex-FDA Commish Warns Of ‘Limbo’ For COVID-19 LDTs Granted Emergency Use Authorization
Scott Gottlieb took to Twitter on the morning of 22 August to question the wisdom of a move this past week by the US HHS to strip away the FDA’s oversight of laboratory developed tests for the novel coronavirus.