IOM 510(k) Committee Publishes Recap Report As It Mulls Reforms
This article was originally published in The Gray Sheet
Executive Summary
The Institute of Medicine committee charged with reviewing the public health effectiveness of FDA's 510(k) review process published a report recapping its work to date, in a lead-up to formal reform recommendations.
You may also be interested in...
Hamburg: FDA Aims To Issue 510(k) Reform Plan By Year-End
FDA hopes to issue a list of planned 510(k) reforms by the end of the year, Commissioner Margaret Hamburg told more than 1,700 device industry stakeholders Oct. 20 at AdvaMed's annual conference in Washington, D.C.
Hamburg: FDA Aims To Issue 510(k) Reform Plan By Year-End
FDA hopes to issue a list of planned 510(k) reforms by the end of the year, Commissioner Margaret Hamburg told more than 1,700 device industry stakeholders Oct. 20 at AdvaMed's annual conference in Washington, D.C.
FDA Maps Out Potential 510(k) Reforms In Long-Awaited Report
FDA released its highly anticipated proposals for reforming the 510(k) program last week, and industry reps acknowledged that many of the individual recommendations could benefit companies