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MDICx - A Case Study in How Patient Preference Information Contributes to R...

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MDICx Webinar

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MDICx Series: A Case Study in How Patient Preference Information Contributes to Regulatory Decisions for Medical Devices

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 will share their experience in working with CDRH on the development of this patient preference survey. Representatives from CDRH will share their perspectives on what they were looking for, as well as the Center’s commitment to partner with patients.

MDICx Webinar

Monday, December 4, 12:00 p.m. Eastern / 11:00 a.m. Central / 9 a.m. Pacific

Speakers:

  • Martin Ho, MS, Associate Director for Quantitative Innovation, US FDA Center for Devices and Radiological Health
  • Frank Hurst, MD, FACP, FASN, Medical Officer, Division of Reproductive, Gastro-Renal, and Urological Devices, Office of Device Evaluation, US FDA Center for Devices and Radiological Health
  • Todd Snell, Senior Vice President, Quality Assurance, Regulatory and Clinical Affairs, NxStage Medical


*By attending the MDICx Series, you are interested in learning information about MDIC, it's projects and endeavors and agree to receive our e-newsletter updates.

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