JD Supra

FDA’s Refreshed Approach to Device Safety Would Require Major Changes to 510(k) Program

On November 26, 2018, FDA Commissioner Scott Gottlieb and device center director Jeff Shuren issued a statement outlining a plan to modernize the 510(k) premarket review program to bolster medical ...
JD Supra

Medical Device Update: FDA Publishes Three New Guidance Documents for the 510(k) Premarket Notification Program

The latest efforts by the U.S. Food and Drug Administration (FDA) to modernize regulation of the 510(k) program come in the form of a trio of new draft guidance documents regarding its Premarket ...
HealthLeaders Media

FDA Criticized for Unsafe Medical Device Approval Process

Eight serious loopholes and cracks in the U.S. Food and Drug Administration's approval process allow potentially unsafe, ineffective yet high-risk machines and materials to be approved for use on ...
MedCity News

FDA considering imposing 10-year limit when manufacturers choose older predicates

Food and Drug Administration’s modernization plan for its 510(k) process may not be all sweet music to the industry. In a joint statement on Monday describing the modernization effort, Commissioner ...
NPR

FDA Tightening Regulatory Requirements For Some Medical Devices

There's no doubt that surgically implanted medical devices can improve lives. Hip and knee replacements can help people regain their mobility. Drug pumps can deliver doses of pain-relieving medicine ...