Gottlieb Defends US FDA 2019 Budget, Device Safety Plan In House
Executive Summary
Members of a US House Appropriations Subcommittee interrogated FDA Commissioner Scott Gottlieb on the agency's proposed 2019 budget and his newly released device safety plan. One fierce critic, Rep. Rosa DeLauro, D-RI, attacked Gottlieb's efforts to allow third-party certifiers to approve device quality manufacturing processes, and said his safety plan looked like a "high-risk" action plan.
You may also be interested in...
FDA Orders Bayer To Extend Essure Post-Market Study
With increased pressure on US FDA surrounding its approach to safety and growing concerns with Bayer's Essure birth control device, the agency is now requiring the manufacturer to extend a mandated post-market study of women who have been implanted with the product, among other requirements.
House Panel Approves Boosts For FDA Digital Health Plan, Quality Medtech Manufacturing
The US House Appropriations Committee in 2019 wants to give FDA an additional $40m to boost its digital health oversight, $12m more to “create a competitive marketplace for device quality,” and instructs the agency to keep working with Congress on a new laboratory-developed test regulatory path.
New Safety Framework Mixes Current Efforts, New Investments At US FDA
In a new "action plan," FDA is stitching together a plethora of ongoing and proposed initiatives to help spur product safety and quality efforts through increased regulatory authority and more incentives for device-makers.