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.
Alongside the publication of the list, FDA has opened a public consultation to solicit input from patients, industry and health care professionals on improving the list by refining the topics, adding new ones or informing the agency of ongoing or published studies that are relevant to patient preference-sensitive areas.
The list is broken up into four categories: patient values in diagnosis and treatment; relevant clinical endpoints for specific patient populations; patient benefit-risk trade-offs for treatment options or diagnostic approaches; and impact of uncertainty in the benefit-risk tradeoffs. FDA has also broken down the list by individual medical specialty.
FDA says the topics included on the list represent issues where PPI could help its staff better understand the condition and treatment options; inform the agency of patients’ acceptance of benefit/risk in specific areas; explain population-level differences in patient perspectives; or represent areas with a significant public health impact.
“The priorities listed on the webpage may be broadly applicable to many diagnostic/therapeutic areas, while others are specific to a disease/condition or technology,” FDA writes, noting that the list is not exhaustive and may change as patient preference methodologies evolve over time.
Priority List of Patient Preference-Sensitive Areas
, Federal Register Notice