Incorporating voluntary patient preference information over the total product life cycle (Catapult's regulatory round-up - September 2024)

The FDA has issued a draft guidance to propose revisions to the 2016 guidance to reflect the current scope of FDA’s benefit-risk paradigm, which may under appropriate circumstances, include patient preference information (PPI), and to provide additional considerations and practical recommendations based on additional experience evaluating patient preferences regarding devices. This draft guidance also fulfils a commitment in Section V.E. of the Medical Device User Fee Amendments Performance ...