SAVE THE DATE FOR OUR 2019 ANNUAL PUBLIC FORUM ON SEPTEMBER 5, 2019 IN WASHINGTON, DC!
In 2016, CDRH issued its final guidance for the submission of patient preference information as part of a sponsor’s regulatory submission. As part of its commitment to partner with patients, CDRH has indicated willingness to work directly with medical device companies considering including patient preferences as part of their submission and encourages device companies to come to CDRH early to discuss their goals. NxStage, a medical device company that develops, manufactures and markets systems for the treatment of end-stage renal disease and acute kidney failure, submitted information from a patient preference study for a label expansion for their home hemodialysis (HHD) unit. The unit had been previously cleared for home use with a care partner, but patients expressed a desire for solo use of the device. A patient preference study measured patients’ maximum acceptable risk for HHD without a partner instead of in-center dialysis. On this webinar, NxStage shared their experience in working with CDRH on the development of this patient preference survey. Representatives from CDRH shared their perspectives on what they were looking for, as well as the Center’s commitment to partner with patients.