The U.S. Food and Drug Administration (FDA) drafted new guidance on explaining the improvement by the sponsors in the medical devices clinical investigations by including the patient's experiences, perspectives, and other relevant information.
The agency would further approach the patient advisors to discuss their views on sponsors and patient advisors can work together and keep up with the latest advancements in the clinical trial. This will also include patient experiences and preference study that will help in better understanding of the benefit-risk tradeoffs.