Application of Human Factors Engineering Principles for Combination Products: Questions and Answers: Guidance for Industry and FDA Staff From Food and Drug Administration (FDA) πΊπΈ This document is a guidance document titled "Application of Human Factors Engineering Principles for Combination Products" and is intended for industry and FDA staff. It focuses on the topic of combination products. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on September 7, 2023 Other (Public Domain) 0 reuses 0 favorites
Content of Human Factors Information in Medical Device Marketing Submissions: Draft Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) πΊπΈ This document is a draft guidance for the FDA staff and industry on the content of human factors information in medical device marketing submissions. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage filled Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on December 8, 2022 Other (Public Domain) 0 reuses 0 favorites
Guidance on applying human factors to medical devices From Medicines and Healthcare products Regulatory Agency (MHRA) π¬π§ MHRA has published guidance on the importance of applying human factors to medical devices, so they are designed and optimised to minimise patient and user safety risks. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on February 12, 2021 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
List of Highest Priority Devices for Human Factors Review: Draft Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) πΊπΈ This document is a draft guidance for industry and FDA staff, listing highest priority devices for human factors review. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage filled Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on May 14, 2019 Other (Public Domain) 0 reuses 0 favorites
Applying Human Factors and Usability Engineering to Medical Devices: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) πΊπΈ This document provides guidance on applying human factors and usability engineering to medical devices for industry and FDA staff. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage filled Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on February 9, 2019 Other (Public Domain) 0 reuses 0 favorites