Regulatory Guidance

FDA Guidance on the Q-Submission Program

Check out LHF's analysis of the new FDA guidance on the Q-Submission Program! A must-read for anyone interested in interacting with the FDA!

A Summary of Risk Management Tools for Human Factors

LHF's summary of Edmond Israelski and William Muto's Risk Management in Human Factors book. Learn how to conduct a uFMEA and FTA!

Summary of MedTech Intelligence’s Webinar from Nov 30th, 2021

I recently attended a webinar hosted by MedTech Intelligence called “EU MDR Lessons Learned.” The webinar content was presented by three...

FDA Final Rule on the Use of Symbols in Labeling

Introduction The use of “stand-alone symbols” or symbols without corresponding explanatory text in medical device instructions offers...

Updates from the FDA CDRH Human Factors Team 2019

A few interesting things I learned from the FDA HFPMET at this year's HFES healthcare symposium.

Update on Hospital Access Challenges

The good news is that the FDA has published a report on the importance of observational research.

FDA/CDER Workshop Highlights

Last week I attended the sixth annual HFES International Symposium on Human Factors and Ergonomics in Health Care in New Orleans, LA,...

FDA Draft Guidance - Comparative Use HF Studies in an ANDA

In January, 2017 the US FDA published a draft guidance, Comparative Analyses and Related Comparative Use Human Factors Studies for a...