Medtech Insight is part 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

UsernamePublicRestriction
UsernamePublicRestriction

Human Factors Questions Drive Rise In FDA Inter-Center Consults

This article was originally published in The Gray Sheet

Executive Summary

Formal consultations between FDA's product centers are becoming more frequent, and they are often triggered by questions about human factors issues, says Office of Combination Products Director Thinh Nguyen.

You may also be interested in...



Reducing Waste In Combo Product Reviews: FDA Goes Lean

The agency disclosed plans to leverage "lean" management techniques, frequently employed in the private sector and by health care organizations, to streamline the process for reviewing new combination products.

Reducing Waste In Combo Product Reviews: FDA Goes Lean

The agency disclosed plans to leverage "lean" management techniques, frequently employed in the private sector and by health care organizations, to streamline the process for reviewing new combination products.

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

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review process to bring more consistency in human factors requirements for combination products, resulting in a recent draft guidance document.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

Topics

UsernamePublicRestriction

Register

OM004967

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel