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FDA Proposes Accelerated Medical Device Approval Process

Medical device testing lab

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23 April 2014. The U.S. Food and Drug Administration proposed yesterday a change in its approval processes for devices that meet unfilled treatment or diagnostic needs of patients with serious medical conditions. The Expedited Access Pre-market Approval Application, says the agency, is designed to speed not only the approval of new medical devices, but also their product development.

FDA also proposed new guidance for its collection of data after initial approval of medical devices to balance reporting requirements with the premarket approval process. The agency is collecting public comments on both proposals for 90 days.

The Expedited Access application aims at speeding up review of pre-market approvals for medical devices that treat or diagnose address unmet needs for life-threatening or debilitating diseases. To invoke this process, a device needs to offer a clinically meaningful advantage over existing technologies and alternatives, and provide a treatment or diagnosis where no approved alternative is available. In addition, applicants need to have a data development plan for the device approved by FDA.

The agency says the process adopts methods from its Innovation Pathway program that brings in regulators at an earlier stage in the product’s development, increases collaboration between regulators and developers, create a better balance between benefit and risk, and make decisions that create momentum to get the device to market. Applicants still need to demonstrate the new device is safe and effective.

“The program allows manufacturers to engage early and often with the agency,” says Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health in an agency statement. “We expect most devices that enter this program will be in the pre-clinical trial phase.”

FDA is also proposing revisions in its procedures for collecting data after initial approval of devices that the agency says complements the Expedited Access program. The proposed procedures, says FDA, outline changes for balancing data collection between pre- and post-market stages in ways that benefit patient access to new devices, while still assuring safety and effectiveness of new devices.

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