510(k) Reform Debate Resurfaces As GAO Completes Mandated Report
This article was originally published in The Gray Sheet
Executive Summary
The device industry is laying the groundwork to respond to an anticipated government report on the effectiveness of the current 510(k) process
You may also be interested in...
GAO 510(k) Report May Recommend Splitting Up Class II, Industry Predicts
Some device industry veterans predict the pending government report on FDA's 510(k) process will include criticisms of the program and may recommend subdividing Class II moderate-risk devices into two or more new categories
GAO 510(k) Report May Recommend Splitting Up Class II, Industry Predicts
Some device industry veterans predict the pending government report on FDA's 510(k) process will include criticisms of the program and may recommend subdividing Class II moderate-risk devices into two or more new categories
Anxiety Over Prospects For Legislative 510(k) Reform Appears To Be Growing
FDA and industry are concerned Congress will revise the 510(k) process and defended the program and warned against statutory reforms during a panel discussion at the Food and Drug Law Institute annual meeting in Washington, D.C