This is great guidance for anyone developing or interested in developing novel medical devices over the next several years.

“The US Food and Drug Administration (FDA) on Thursday published a list of patient preference priority areas that may be useful in developing medical devices and in the agency’s assessment of those devices.  “Patients are the experts in living with their disease or condition, the outcomes that are most important to them, and how they weigh benefits and risks. Through our Patient Preference Initiative, we’ve committed to seeking patient input on these types of topics to help inform our regulatory decision making,” said Center for Devices and Radiological Health (CDRH) Director Jeff Shuren.  Specifically, FDA says the list is focused on the patient preference-sensitive areas it believes will have the biggest impact on regulatory decision making, premarket medical device clinical studies and postmarket evaluation.”

Federal Register Notice

Excerpts taken from the origina story (Posted 02 May 2019 | By Michael Mezher)