With the eSTAR Program, the FDA aims to increase the efficiency of approval procedures (e.g., the 510(k) procedure) through digitalization. This article tells you how forward-looking this approach is and whether you should or even must take part. 1. What is the eSTAR Program? The eSTAR Program enables medical device manufacturers to submit their approval…
DetailsThe FDA describes its requirements for Human Factors Engineering in two documents: This article What the FDA calls “Human Factors Engineering” (HFE), IEC 62366-1 calls “Usability Engineering“. The FDA defines the term as follows: 1. How the FDA’s “Human Factors Guidances” interact In the introduction to the document “Content of Human Factors Information in Medical…
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