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FDA Proposes Guidance to Increase Patient Engagement in Medical Device Clinical Investigations


Patients could help advance the development and evaluation of innovative medical devices.


The U.S. Food and Drug Administration (FDA) is backing its promise to focus on evaluating emerging technology. Last week, the agency issued a guidance to increase access to medical devices and announced its participation in two collaborative communities to overcome medical device challenges.

Today, the federal regulator released draft guidance on Patient Engagement in the Design and Conduct of Medical Device Clinical Investigations, which provides recommendations for manufacturers to engage patients in medical device clinical investigation design.

“This draft guidance is a reflection of our extensive work to engage patients into our medical product regulatory processes…” said Ned Sharpless, M.D., acting commissioner of the FDA.

The guidance intends to help sponsors understand how they can use patients’ experiences and perspectives to improve the design and conduct of medical device clinical investigations. The draft also aims to highlight the benefits of engaging with patients early in the medical device development process. The agency also hopes the guidance addresses questions and misconceptions about collecting and submitting to FDA patient engagement information regarding the design and conduct of a medical device clinical investigation.

What’s more, the guidance illustrates which patient engagement activities are not generally considered by the agency to generate research or an activity subject to FDA’s regulations.

The agency believes medical device clinical investigations designed with input from patients could lead to:

  • Faster study and research participant recruitment, enrollment and completion
  • Greater research and study commitment and compliance
  • Fewer protocol revisions
  • Streamlined data collection
  • More relevant data on outcomes that matter to patients

The draft includes approaches sponsors can use to engage with patient advisors and outlines patient engagement activities that could enhance the design and conduct of clinical investigations.

Patients could help sponsors improve informed consent documents, so patients better understand them.

“FDA believes that (patients and their family caregivers) can and should be able to provide their insights about a disease or condition, including living with that disease/condition, and the impact of medical devices in the diagnosis, treatment and management of the disease/condition, through engagement activities,” the agency said.

Engaging more patients could lead to more patient-centric clinical investigations and more timely access to innovative, safe and effective medical devices, Sharpless added.

“When we work with patients early-on, we can advance the development and evaluation of innovative medical devices,” said Sharpless. “Patient-centric clinical investigations may improve efficiency and quality in the design and conduct of clinical investigations, ensuring that sponsors can enroll and retain patients and collect information that is more meaningful to patients.”

Individuals may submit a comment about the draft guidance online or via mail by Nov. 22.

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