BioCentury
ARTICLE | Politics & Policy

FDA takes steps to bring diagnostics to patients faster

September 5, 2018 10:39 PM UTC

FDA Commissioner Scott Gottlieb highlighted steps the agency is taking to speed patient access to new medical devices, such as diagnostics, and laid out its framework for review of premarket approval applications (PMAs). Gottlieb unveiled the plans in remarks at the Medical Device Innovation Consortium (MDIC) forum Wednesday in Washington, D.C.

FDA will release its QUiK Review pilot Thursday to modernize the application submission process for specific "well understood, lower-risk 510(k) submissions" with a more streamlined electronic format, Gottlieb said. FDA expects QUiK Review to shorten device review time to 60 days from 90 days...