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Resource Library
FDA & ISO Issued Documentation
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FDA Draft Guidance:
Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products — Content and Format (2023)
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FDA Draft Guidance:
Content of Human Factors Information in Medical Device Marketing Submissions (2022)
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IEC 60601-1-6 Ed. 3.2 (2010 + A1:2013 + A2:2020):
Application of usability engineering to medical devices (2020)
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IEC 62366-1 (2015)/Amd 1:
Application of usability engineering to medical devices (2020)
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ISO 14971:
Application of risk management to medical devices (2019)
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ANSI/AAMI HE75 (2009)/R2018:
Human Factors Engineering - Design of Medical Devices (2018)
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FDA Draft Guidance:
Contents of a Complete Submission for Threshold Analyses and Human Factors Submissions to Drug and Biologic Applications (2018)
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IEC 62366-2:
Medical Devices — Part 2: Guidance on the Application of Usability Engineering to Medical Devices (2016)
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FDA Draft Guidance:
Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development (2016)
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FDA Guidance:
Applying Human Factors and Usability Engineering to Medical Devices (2016)
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