The US Food and Drug Administration (FDA) on Thursday issued a draft guidance that would significantly revise its previous guidance on using voluntary patient preference information (PPI) for medical devices, shifting its focus from the premarket phase to incorporating PPI across the total product life cycle.
The updates are based on lessons it has learned from using PPI data in regulatory decisions since the final guidance was published.
When finalized, the guidance will supersede the agency’s 2016 guidance on the inclusion of PPI in premarket approval (PMA) applications, humanitarian device exemption applications, or de novo requests. The 2016 guidance was part of the agency’s mandate to develop strategies for using voluntary PPI during product development and in regulatory decisions. FDA said the changes in the new draft guidance were made based on its experience with a growing number of industry-sponsored PPI studies, better understanding of PPI trial designs, and other factors…
