MDIC Catalog Outlines Patient Preference Methods
This article was originally published in The Gray Sheet
Sponsors who think patient preference could be a key factor to the approval of their device can look to the appendix section of the new MDIC report for study methods that can help support claims with information showing that patients may be willing to take on more risks to get their hands on the treatment.
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US FDA released a final guidance aimed at helping sponsors and other stakeholders interested in using patient-preference information to make their case for a device application. The agency has decided to keep its labeling recommendation in the final guidance despite industry objections.
FDA draft guidance lays out how to collect patient preference data and how to present the preferences on device labels. The guidance supports a growing emphasis by FDA to formally incorporate patient input into regulatory decision-making.
The public-private Medical Device Innovation Consortium issued a report outlining strategies for incorporating patient preference data into device applications.