New plan by FDA will help critically sick get early access to care

The U.S. Food and Drug Administration proposed a new program aimed at speeding up approvals for medical devices for patients who have no other treatment options available, on April 22.

LOS ANGELES, CA (Catholic Online) - Called the Expedited Access Premarket Approval Application program, the program is focused on increasing interactions between the FDA and medical equipment companies, in response to criticisms by policymakers and patient groups, which claim that the FDA process for approving medical devices to those in need is too inefficient and slow, which harms the patients.

The program is aimed at reducing the time it takes to develop a product, and then get it into the hands of those who need it. It follows another new program by the FDA intended to speed up the development of certain cancer drugs at the clinical trial stage, said Morningstar analyst Debbie Wang.

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"This is yet another aspect of how FDA is trying to work in a more coordinated fashion so they can reduce the number of false starts and situation of reinventing the wheel," Wang said. The program will "help put some priority on which therapies are going to affect the most patients with the greatest need."

If a device features some sort of technological breakthrough and has significant benefits over existing products, then it can be eligible for the program.

The program is designed as a response to dragging review times on numerous new product applications. Increases in fees paid by the industry to fund the FDA's work could allow the agency to put more manpower into the application process.

In September of 2013 the FDA issued a rule that required manufacturers of devices to put unique codes on their products to enable them to be regulated for safety reasons. The agency also issued final rules for using mobile medical apps, regulating only apps that turned smartphones into currently regulated devices, such as devices which determine if a patient is having a heart attack.

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