Regulatory News In Brief
This article was originally published in The Gray Sheet
Executive Summary
CDRH 510(k), strategic priorities update
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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, AAMI Form Action Plan, Safety Council To Fix Infusion Pump Problems
FDA and the Association for the Advancement of Medical Instrumentation are launching an infusion device safety council to help implement improvements to infusion pump safety
FDA User Fee Renewal Should Include Pre-Market Improvements - Industry
Consumer advocates are suggesting FDA request considerably more funding from device companies in the next round of user fee negotiations, but companies are reluctant to foot more of the bill for device reviews without seeing promised improvements in FDA's pre-market program