Streamlining your FDA human factors approval process.
You know that the FDA requires Human factors for the approval of most medical devices and combination products.
How will you comply with these requirements in an expedient manner, avoiding costly delays in the approval process?
Do you have the evidence necessary to demonstrate that your device design has addressed use risk problems?
How do you collect this evidence, and how should it be presented to facilitate a problem-free review by FDA?
Call us for a free 30 minute discussion about how we can help you with these questions!
Learn how to navigate the FDA post-market databases to identify key usability issues with marketed medical devices and combination products!
March 27, 2019
FDA CDER Releases New Human Factors Guidance in September 2018
Guidance covers preferred formats for Human Factors Validation Studies and Human Factors Validation Study reports. Also covered are threshold analyses and comparitive studies.