US FDA Issues Guidance On Human Factors Studies For Combination Products
By Chris Gosnell
Gross, M., Shames, A. (2016). US FDA Issues Guidance On Human Factors Studies For Combination Products. This is the second in a series of articles covering quality system requirements for combination products and borderline products in the US and EU. In February 2016, the US FDA issued three guidance documents which focus on identifying, assessing and mitigating hazards related to how people use medical products that include a medical device.