What's Next For LDTs? FDA May Be Eyeing A New Game Plan
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.
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Gottlieb At The Medtech Conference: US FDA Commissioner Talks About CDRH Innovation, Puerto Rico, LDTs And More
Check out the full video and read the highlights of US FDA Commissioner Scott Gottlieb's keynote address and Q&A from AdvaMed's 2017 Medtech Conference. Among the issues addressed: Gottlieb touted the agency's device center as the spark of innovation within FDA, and he provided a key update to the agency's digital-health regulation, his hopes for lab-developed test regulations and some substantive points on how industry should respond to the ongoing devastation in Puerto Rico from Hurricane Maria.
Dx Departure: US FDA's Diagnostics Chief Gutierrez Steps Down
Alberto Gutierrez left FDA and government this week in a planned retirement. He was director of the office that oversees pre- and post-market programs for in vitro diagnostics and radiology devices, an office where several holes already exist in top management slots.
FDA's Document Dump: Guidance Release Skyrocketed In Advance Of Trump
Uncertainty about US FDA's direction under the new president may have spurred staff to ensure views on several issues released before administration changed.