FDA medical device clinical trials Regulations

Moderator: Heather Howell

Coordinator: Welcome and thank you for standing by. At this time all participants are in a listen-only mode. During the question-and-answer session, please press star 1 on your touch-tone phone. Today’s conference is being recorded. If you have any objections, you may disconnect at this time. Thank you and you may begin.

Heather Howell: Hello and welcome to today’s FDA Webinar to discuss the final guidance document titled IDEs for Early Feasibility Medical Device Clinical Studies Including First in Human.

Your presenters today are Andrew Farb and Dorothy Abel, both of the Office of Device Evaluations Division of Cardiovascular Devices. Following their presentation we will open the call to questions. Now I’ll turn the call over the Andrew Farb.

Andrew Farb: Good day, everyone. I’m happy to present a brief overview of the guidance on (inspecificational) device exemptions for early feasibility medical device clinical studies so to begin, there are clear opportunities associated with conducting early feasibility studies in the United States.

Performed in the United States, these studies allow for contact between investigators, developers, inventors and regulators in geographically closer locations and in more collaborative fashion.

We need to keep the patient in the center of our focus and when these studies are performed in the United States, they allow for access of promising new technology earlier in the device development process, in a more continuous fashion for early feasibility studies through clinical trials and then it expanded dissemination once beneficial devices are approved for use in the general population.

FDA’s goals in this effort are to provide the earliest and broadest patient access to beneficial medical devices and maintain or regain U.S. leadership in innovation but prevailing currents need to be recognized. Initial clinical testing of novel devices has been moving to non-U.S. sites.

Device innovation may follow overseas and we now know that some devices are being exclusively developed for non-U.S. (in country). There are real world consequences to these developments. There can be a palpable time lag in the availability of some beneficial medical devices for U.S. patients.

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BMC Medical Research Methodology at the 35th Annual Conference of the ..  — BMC Pediatrics
The conference will focus on issues such as design and analysis of clinical trials, methods in biostatistics and development of clinical prediction models.

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