Final Guidance Encourages Use Of Patient Preference In Device Applications
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.
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The FDA has expressed interest in using patient preference information (PPI) to make regulatory decisions for medical devices. A recent article gives recommendations to medical device sponsors who want to study PPI in clinical trials.
The public-private partnership has launched an initiative that aims to help regulators address digital health – in particular the US FDA’s pre-cert pathway for certain medical software.
As the agency continues to incorporate more patient-preference data into its regulatory process, it is asking stakeholders on the kinds of diseases and other factors it should consider when evaluating patient-preference information. The feedback is ultimately meant to inform regulators and sponsors about what patients want as they develop products.