According to the U.S. Food & Drug Administration (FDA), “patients can and should bring their own experiences to bear in helping inform the agency’s evaluation of medical devices over the total product lifecycle. This kind of input can be important to consider during the FDA’s decision-making for medical devices including in clinical studies, benefit-risk assessments, and postmarket surveillance.” Unfortunately, when it comes to seeking patient input in the evaluation of medical devices, the category of “Pulmonary” is not included in FDA’s list of priorities, and the US COPD Coalition strongly believes that it should be.
The USCC has submitted comments to the FDA asking that the category of “Pulmonary” be added to the FDA’s Priority List of Patient Preference-Sensitive Areas. See the comments submitted by the USCC here: