US: FDA publishes list of priority patient preference areas for medical devices

05-05-2019

US: FDA publishes list of priority patient preference areas for medical devices

(Source: RAPS 2019-05-06)

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.

The list was put together based on a framework created during a 2017 public workshop and is part of the agency’s commitments under the Medical Device User Fee Amendments of 2017 (MDUFA IV) to further incorporate PPI in its regulatory decision-making.

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