Regulatory News In Brief
This article was originally published in The Gray Sheet
CDRH 510(k), strategic priorities update
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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 and the Association for the Advancement of Medical Instrumentation are launching an infusion device safety council to help implement improvements to infusion pump safety
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