On May 29, 2026, the FDA issued the final guidance on human factors information in medical device marketing submissions to CDRH. The guidance introduces several notable changes from the 2022 draft, including describing a new risk-based decision framework that may reduce the need for human factors validation testing for some devices. LHF's Senior HF Engineer Hannah Cutright highlights the most significant updates and what they mean for device manufacturers preparing FDA submis

Read about the FDA's new guidance, which details how medical device manufacturers can include pre-planned modifications in their submission.