Category: Food & Drug Administration (FDA)
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.
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.
The FDA reportedly grounds an internal feasibility study of using unmanned drones in facility inspections.
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.
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.
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.