Ep.001 Safe and Effective Podcast: FDA Human Factors Regulatory Roundup (ft. Janet Creaser)

Episode 001: In this debut episode of Safe and Effective, our host Heidi Mehrzad, brings you an exciting blend of regulatory insights and live interviews from this year’s #HFESHealthcareSymposium in Orlando, Florida.

In our first #RegulatoryRoundup segment ever, we talk to Janet Creaser about the FDA’s newest #HumanFactors draft guidance released in December 2022, "Content of Human Factors Information in #MedicalDevice Marketing Submissions". We discuss its content, goal, and use, while pointing out some of its advantages and downsides.

• FDA Draft Guidance (December, 2022): Content of Human Factors Information in Medical Device Marketing Submissions

Additionally, in this episode we share insights from the 2023 HFES International Healthcare Symposium in Orlando, Florida, from our field correspondent who interviewed some of its organizers.

Listen to the podcast here or on your favorite podcast platform.

#safeandeffectivepodcast#humanfactors #hfe #usability #podcast #pharma #regulatoryroundup #hfes #healthcaresymposium #fda #humanfactorsengineering #medical

Research Links for this episode:

• Human Factors Cast: https://www.humanfactorscast.media

• Human Factors Cast Podcast Network Patreon: https://www.patreon.com/humanfactorscast

• Human Factors Minute: https://www.humanfactorsminute.com