Final Guidance Encourages Use Of Patient Preference In Device Applications

US FDA has finalized a guidance in its push toward using patient-preference information (PPI) when reviewing medical device applications. In some cases where a product does not meet the agency's threshold for safety and efficacy, the agency could use input from patients, physicians and caretakers in the form of PPI to give a positive decision.

Over the years, FDA has been working with various stakeholders – including patient advocacy groups and industry – to get a better grasp of how PPI could be used in their decision-making process