Consumer Information for Medical Devices Update: Announcing the Patient & Care-Partner Connection Program

The U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) is looking for public comment on the scope and nature of a new Patient & Care-Partner Connection program, intended to build upon our efforts at conducting meaningful patient engagement. We’ve designed the program to provide CDRH staff with a formal process they can use to engage with patients and care-partners regarding their experiences with medical devices and their treatment. The program will not be used to solicit external policy advice or opinion.

The program is directly tied to one of CDRH’s strategic priorities to “Partner with Patients,” aimed at fostering continuous engagement with patients, care-partners, and patient advocates during the development and evaluation of medical devices.

We welcome your comments regarding the scope and nature of the Patient & Care-Partner Connection program and how the FDA can effectively partner with patient organizations. The comment period will be open for 60 days in the Federal Register under docket number: FDA-2016-N-3462.

For more information about CDRH’s commitment to patient engagement, visit CDRH’s Patient Engagement webpage.

Thank you,

Food and Drug Administration
Center for Devices and Radiological Health