Posted by Michael Wonder on 31 Aug 2020
FDA releases draft guidance on PROs for device manufacturers
31 August 2020 - Device manufacturers have new draft guidance from the US FDA for the selection of patient-reported outcome instruments in clinical evaluation of their products.
The guidance details such topics as modification or adaptation of existing instruments, and the possibility of nesting patient-reported outcome instruments within real-world data sources.
The new draft was jointly issued by the Center for Devices and Radiological Health and the Center for Biologics Evaluation and Research. The document lays out general principles for manufacturers on the selection, development and modification of instruments to capture patient-reported outcomes.
