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September 29, 2015

NPAF Encourages Medical Product Developers to Consider Patient Perspective

2015-09-29 | August 17, 2015

(Washington, DC) In response to an FDA-issue proposed guidance, “Submission, Review in Premarket Approval Applications, Humanitarian Device Exemption Applications, and De Novo Requests, and Inclusion in Device Labeling,” the National Patient Advocate Foundation (NPAF) highlighted the importance of encouraging developers of all medical products to include more fully the patient perspective on a variety of topics.

The proposed guidance sought feedback on how to improve the collection and submission of patient preference information associated with the use of devices.

In response to the guidance, NPAF wrote:

NPAF strongly agrees that patients can and should bring their own experiences to bear in helping the Agency evaluate the benefit-risk profile of certain devices, and that this kind of input can be important to consider during regulatory decision-making.  As such, we applaud the Agency for outlining and providing clarity to the process behind securing and presenting patient preference– it is vital that patients are given the opportunity to provide feedback throughout the entire process, and we appreciate the Agency’s recognition that such patient information is critical at all steps of the product life cycle.  We believe that through the continual development and refinement of methods for eliciting patient preferences regarding benefits and risks associated with use of devices, when finalized, this guidance can serve as a catalyst for the advancement of science.

In the comment letter, NPAF notes that meaningful and appropriate engagement of patients and patient preference information should be incorporated into all stages of development and regulation of medical devices — not only during the early stages of product development, but also for post-market activities.

“Patient preference information is paramount for healthcare providers and patients in making decisions involving difficult benefit-risk tradeoffs or novel tradeoffs,” said George Dahlman, NPAF Executive Vice President. “As we increasingly trend towards personalized care, incorporating the patient perspective as early as possible will only increase the quality of care a patient receives.”

The entire text of the comment letter is available on the NPAF site.