Through a grant from the U.S. Food and Drug Administration (FDA), investigators at the Yale University School of Medicine are conducting a survey of medical device manufacturers to better understand post-market clinical research activities. Specifically, Yale is interested in post-market clinical research for medical device products approved via the Premarket Approval (PMA) pathway. Results from this project are intended to establish the scope, costs, and purpose of current medical device manufacturer post-market clinical research efforts and will inform surveillance initiatives at FDA/Center for Devices and Radiological Health (CDRH).
MassMEDIC, in addition to trade associations representing medical device manufacturers with operations in California, Indiana, and Minnesota, is partnering with Yale to disseminate the survey. In the next few days you will receive an email from firstname.lastname@example.org with a link to the survey, which will be administered via the Qualtrics Survey Tool. Please complete it, which will take approximately 15-30 minutes, at your earliest convenience or forward to the appropriate individual in your organization. Your responses will be confidential.
While results of this survey will be disseminated to the FDA/CDRH, Yale will also provide summary findings back to participating manufacturers as a means of thanking member organizations that participate. We appreciate your time and consideration and thank you in advance for participating in this important work. Please do not hesitate to contact MassMEDIC or Yale with additional questions or for clarification.