FDA Puts Lab-Developed Test Oversight Plans On Hold
After years of wrangling over lab-developed test regulations with laboratory lobbyists, FDA has put its plans to finalize a guidance that lays out its oversight framework for LDTs on hold as a new Congress and a new deregulation-focused president-elect is set to take the helm.
You may also be interested in...
No significant trends emerged in diagnostics M&A or financing this past year, which did see the introduction of several government-funded initiatives, elements of which will bolster diagnostics innovation. As in other sectors of health care, the biggest question is how the incoming Trump administration could change US regulatory and funding policies.
Following the agency's signal to stakeholders that it will not be finalizing a regulatory framework for laboratory-developed tests this year, industry experts suggest some other approaches FDA could take to address lab tests of all stripes.
FDA’s decision to hold off on finalizing its guidance on oversight of lab-developed tests is an acknowledgement of the new US political dynamics after the Nov. 8 elections. It may also be an important signal of where early attention will fall at FDA after the transition: on the devices, not drugs.