Module 18 - Drug Device Combinations and Other Technologies

07/12/2023

What are the current Human Factors and Usability Engineering regulations?

The Organisation for Professionals in Regulatory Affairs

Human Factors for drug device combination products

19

What are the current Human Factors and Usability Engineering regulations?

Medical Devices: Application of Usability Engineering to Medical Devices.

2015

IEC 62366-1

FDA Guidance: Applying Human Factors and Usability Engineering to Medical Devices FDA Draft Guidance: Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development. MHRA Guidance: Human Factors and Usability Engineering – Guidance for Medical Devices including Drug-device Combination Products v1.0. FDA Guidance: Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-device Combination Product submitted in an ANDA. Packaging for terminally sterilised medical devices – Part 1: Requirements for

FDA – Medical Devices

2016

FDA – Combination Devices

2017

MHRA HFE Guidance

2017

FDA – Generic Devices

2018

ISO 11607 1:2019

2019

materials, sterile barrier systems and packaging systems. European Medical Device Regulation, 2017/745/EC.

EU MDR 2017/745/EC

2020

The Organisation for Professionals in Regulatory Affairs

Human Factors for drug device combination products

20

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