Regulatory News In Brief
This article was originally published in The Gray Sheet
Executive Summary
Human factors guidance
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FDA To Clarify Scope Of Devices Covered By Human Factors Guidance
FDA is reviewing 600-plus comments on its draft human factors guidance and plans to "be much more specific" in the final version about the types of devices subject to the new data recommendations.
AAMI To Address Reprocessing Concerns In “Technical Reports” Due In 2013
Reports are being developed with input from FDA and will cover endoscope reprocessing, standardized cleaning instructions and human factors for device reprocessing.
Massachusetts Device Makers Urge FDA To Abandon Controversial 510(k) Reform Proposals
Massachusetts device makers are pressing FDA to abandon the controversial 510(k) reform recommendations currently awaiting input from the Institute of Medicine.