Medtech Insight is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

Podcast + Q&A: Combo Product Human Factors Guidance Follows Multi-Year Coalition Effort

This article was originally published in The Gray Sheet

Executive Summary

Combination Products Coalition's Bradley Thompson discusses how the organization lobbied for changes to FDA's review process to bring more consistency in human factors requirements for combination products, resulting in a recent draft guidance document. Listen to the "Gray Sheet" podcast interview and read the Q&A.


Related Content

FDA Guidance Sheds Light On Human Factor Studies For Combo Products
Combo Product Reforms Are A Priority For Next User Fee Round, FDA Officials Say
Human Factors Questions Drive Rise In FDA Inter-Center Consults