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.
You may also be interested in...
The Senate would provide US FDA’s device program with a slight 2.2% boost in 2019 spending, to $299.99m, under numbers approved by the Senate Appropriations Committee May 24. But device activities ultimately could see a lot more next fiscal year, as the House is seeking $368.24m.
More than 80 industry, laboratory, health-care provider and patient groups sent a letter to two congressional committees, urging them to advance a bill to modernize the current way FDA regulates diagnostic tests, including possibly a new regulated product category that combines laboratory developed tests and in vitro diagnostics.
US FDA laid out its proposed starting model to launch the pre-certification program for digital health products, including a matrix for when pre-certified app and software developers could bring new or modified products to market with either streamlined or no pre-market review.