LDT Rule Will Have Massive Impact, Analysts Say; Fundamental Questions Remain
Stakeholders are still processing the US FDA’s proposed rule that would place lab-developed tests under its regulatory purview. While only time will tell what it all means, it is already clear that the agency’s action, if finalized, will significantly affect the healthcare industry and above all patients.
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Investors and business executives weighed in on the FDA’s proposed rule on LDTs during a panel at the Medtech Conference on 9 October.
An apparent spike in health care enforcement actions by the US Department of Justice has led to hundreds of millions of dollars in penalties and multiple jail sentences throughout the sector. The DOJ has announced at least 20 device-related cases since mid-September.
A proposed rule from the US Food and Drug Administration would allow the agency to take on regulation of lab-developed tests by phasing out the previous approach of enforcement discretion