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Congressional panel wants priority review program for medtech

January 27, 2015 by Brian Johnson

21st Century Cures, a bipartisan panel led by Reps. Fred Upton (R-Mich.) and Diana DeGette (D-Colo.), calls for the FDA to create a new, expedited review process for medical technology designed to address unmet needs.

Congressional panel wants priority review program for medtech

A congressional panel is calling fora new, expedited priority review process for medical technology aimed at unmet medical needs, similar to similar programs for drugs and biologics.

Report: FDA grounds plan to test unmanned inspection drones

December 19, 2014 by Brian Johnson

The FDA reportedly grounds an internal feasibility study of using unmanned drones in facility inspections.

Report: FDA grounds plan to test unmanned inspection drones

An FDA proposal to test unmanned drones in facility inspections was grounded before it could take flight, according to a report in Regulatory Focus.

An internal FDA memo obtained by the publication revealed that the agency was planning to "perform a test of drone technology" sometime this week.

FDA honcho Maisel: Study could downgrade some high-risk devices

December 12, 2014 by Brian Johnson

Dr. Bill Maisel, deputy director for science at the FDA's Center for Devices & Radiological Health, tells medtech execs the agency is halfway through its review of the PMA process, which could result in some devices being removed from the high-risk category.

FDA honcho Maisel: Study could downgrade some high-risk devices

The FDA is about halfway through a retrospective study of its pre-market approval program, a review that could result in some devices being removed from the highest-risk category, according to Dr. Bill Maisel, deputy director for science at the FDA's Center for Devices & Radiological Health.