FDA Seeks to Ease Burden for Medical Device Approvals

July 29th, 2015

The Food and Drug Administration (FDA) published a blog last week on the agency’s recent efforts to reduce the hurdles to get medical devices approved.  The blog was authored by FDA Director of Reproductive, Gastro-Renal and Urological Devices, Ben Fisher, in the Office of Device Evaluation. The FDA is working on implementing new measures and policies to minimize the time and cost of clinical trials, in hopes of incenting medical device manufacturers to conduct clinical trials in the United States (US) and more immediately serve American patients.

The blog explains that the agency is attempting to better leverage existing publicly available clinical data for medical devices to improve the clinical trial design.  The FDA has also applied an objective performance criterion (OPC), a statistical analysis model, to recent clinical trials to determine the “minimum acceptable success rate for demonstrating device effectiveness.”  Fisher writes, “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.”

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