Bioelectronics Corp (BIEL)

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Improving Access to Medical Devices: FDA Uses Existing Clinical Data to Reduce Premarket Data Needs

Posted on July 24, 2015 by FDA Voice
By: Ben Fisher, Ph.D.

At the FDA, we recognize the value of encouraging medical device innovation. We recently have acted to reduce the time and cost of clinical trials while maintaining patient protections. By doing so, FDA is helping to ensure that manufacturers will be more likely to conduct their clinical studies in the U.S., and patients in this country will have earlier access to innovation.

One way the FDA can reduce the time and cost of a clinical trial is to determine if publicly available clinical data for medical devices with which we have considerable experience can be leveraged to develop a less burdensome clinical trial design.

The FDA has established a strategic priority of strengthening the clinical trial enterprise. This includes finding ways to streamline clinical trials so that fewer resources are required to bring a new device to the market.

Through strengthening the clinical trial enterprise, we hope to encourage manufacturers to study new and important medical devices in the U.S., helping us fulfill our vision of providing patients with high-quality, safe and effective medical devices of public health importance first in the world.


http://blogs.fda.gov/fdavoice/index.php/2015/07/improving-access-to-medical-devices-fda-uses-existing-clinical-data-to-reduce-premarket-data-needs/