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  1. FDA In Brief

FDA In Brief: FDA issues first report on patient reported outcomes in medical device premarket submissions and postmarket studies

For Immediate Release: Dec. 12, 2017

Media Inquiries

  Stephanie Caccomo
  301-348-1956

"Considering patients’ perspectives is critically important in medical device development and evaluation. The FDA is committed to including their voices in the evaluation of medical devices over the total product life cycle. The significant increase in the number of product applications submitted with patient perspective information shows that manufacturers, like the FDA, recognize the value of this information. We look forward to collaborating with our industry partners and patient groups to increasingly assess the patient perspective and to clarify how such information should be collected and reviewed,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health."

Today, the FDA’s Center for Devices and Radiological Health (CDRH) issued its first report on patient reported outcomes (PRO) included in premarket submissions and postmarket studies of medical devices. When used in clinical studies, PRO measures are a standardized method of collecting a patient’s perception of their own health status, which can provide helpful information to the FDA in making a benefit-risk determination for medical devices. Making patients a partner in the FDA’s premarket and postmarket activities is a CDRH strategic priority and, as part of this effort, the agency committed to take into consideration relevant and reliable evidence of patient perspectives into premarket review decisions, including both patient preference information and PRO. This reports details how the agency has encouraged the appropriate use of PRO in regulatory studies and decisions, provides case studies and other examples on PRO collection in both premarket and postmarket clinical studies, and identifies areas for potential future collaboration with stakeholders.

The FDA has seen a significant increase in the amount of PRO submitted by medical device manufacturers. In fiscal year 2017, more than 75 percent of approved investigational device exemptions included a PRO measure. The report outlines the many steps that the agency is implementing to meet the significant increase in PRO data, including training and education for staff on reviewing the PRO data. The FDA continues to encourage manufacturers to submit this information about the patient voice in regulatory decisions. Today’s PRO report provides an update on the agency’s significant progress to date and plans for future inclusion.

The FDA also has activities underway to foster more PRO in drug development, including the Patient-Focused Drug Development effort in the Center for Drug Evaluation and Research, and ongoing work within the Oncology Center of Excellence.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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