Application of human factors engineering principles for combination products: questions and answers : guidance for industry and FDA staff

Application of human factors engineering principles for combination products: questions and answers : guidance for industry and FDA staff

Collection:
Health Policy and Services Research
Contributor(s):
United States. Food and Drug Administration. Office of Combination Products, issuing body.
United States. Food and Drug Administration. Office of the Commissioner, issuing body.
Center for Devices and Radiological Health (U.S.), issuing body.
Center for Drug Evaluation and Research (U.S.), issuing body.
Center for Biologics Evaluation and Research (U.S.), issuing body.
Publication:
Silver Spring, MD : Center for Devices and Radiological Health, September 2023
Language(s):
English
Format:
Text
Subject(s):
Bioengineering
Device Approval
Drug Development
Drug Industry
Ergonomics
Government Regulation
United States
Genre(s):
Guideline
Technical Report
Abstract:
This document contains questions and answers for industry and FDA staff on the application of human factors engineering (HFE) principles to the development of combination products as defined under 21 CFR part 3. This guidance finalizes the February 2016 draft version entitled Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development. This guidance provides information in a question and answer format and clarifies how the unique aspects of a combination product influence the considerations within the HFE process. This guidance should be used in conjunction with the guidance for industry and FDA staff Applying Human Factors and Usability Engineering to Medical Devices and with the guidance for industry Safety Considerations for Product Design to Minimize Medication Errors. Additionally, this guidance supplements other existing guidance documents developed by the Center for Biologics Evaluation and Research (CBER), the Center for Devices and Radiological Health (CDRH), the Center for Drug Evaluation and Research (CDER), and the Office of Combination Products (OCP) that describe other aspects of product development. In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
Copyright:
The National Library of Medicine believes this item to be in the public domain. (More information)
Extent:
1 online resource (1 PDF file (14 pages))
NLM Unique ID:
9918716788406676 (See catalog record)
Permanent Link:
http://resource.nlm.nih.gov/9918716788406676