FDA Passes The Buck On LDTs, But Floats Ideas
The US agency has backed away from its intent to oversee laboratory-developed tests as set out in a controversial 2014 draft guidance. Instead, in a new discussion paper it is advising legislation to handle the issue. The agency also urges LDT developers to consider recommendations to increase transparency.
You may also be interested in...
Experts say either would likely prioritize issues such as the coronavirus pandemic and the medical supply chain, but they would diverge in areas like laboratory developed test reform.
The medical device advocacy group plans to include laboratory developed test reform in their upcoming user-fee negotiations with the US FDA.
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.