FDA Draft Guidance on Predetermined Change Control Plans: Implications for Medical Device Manufacturers
Read about the FDA's new guidance, which details how medical device manufacturers can include pre-planned modifications in their submission.
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Laurie Reed
Mar 225 min
Conducting an Aseptic Presentation Study
Rebecca Lee
At the 2024 HFES (International Human Factors Symposium), Laurie and Jan shared key study design considerations for testing
Beth Loring
Jun 27, 20235 min
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!
Beth Loring
May 8, 20232 min
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!
Beth Loring
Dec 14, 20214 min
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...
Beth Loring
Sep 21, 20213 min
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...
Beth Loring
Apr 24, 20193 min
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.
Beth Loring
Jan 22, 20181 min
Update on Hospital Access Challenges
The good news is that the FDA has published a report on the importance of observational research.
Beth Loring
Mar 17, 20173 min
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,...
Beth Loring
Feb 7, 20172 min
FDA Draft Guidance - Comparative Use HF Studies in an ANDA
In January, 2017 the US FDA published a draft guidance, Comparative Analyses and Related Comparative Use Human Factors Studies for a...
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