The U.S. Food and Drug Administration has proposed speeding up medical device approvals for patients who have no other treatment options through a new program focused on earlier and more frequent interactions between companies and FDA staff.
The Expedited Access Premarket Approval Application program is a response to criticisms by policymakers, patient groups and industry that the FDA process for approving medical devices is inefficient and slow, delaying patients’ access to new, helpful products.
The program is not a new pathway to market, the agency says, but rather a change in approach aimed at reducing the time it takes to develop a product and get it to market.
It is similar to a new FDA program intended to expedite development of certain cancer drugs in the clinical trial stage, Morningstar analyst Debbie Wang says.
“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 situations of reinventing the wheel, and to help put some priority on which therapies are going to affect the most patients with the greatest need,” Wang says.
A device can be eligible for the program if it features breakthrough technology with significant benefits over existing products.
In recent years, review times dragged out as the FDA faced a rising number of new product applications. Recent increases in the user fees paid by industry to fund FDA work could be providing more wiggle room for the agency to devote manpower to improving the application process, Wang says.
The FDA issued a rule in September that requires device manufacturers to put unique codes on their products to enable regulators to track and monitor them in the event of a safety problem.
Also in September, the agency issued final rules on mobile medical apps, saying it would only regulate apps that transform smartphones into devices that the agency currently regulates, such as electrocardiography machines, which can determine whether a patient is having a heart attack.
The FDA has also published draft guidance on when data can be collected after a product’s approval and what actions the agency can take if approval conditions such as post-market data collection are not met. The regulator is now seeking public comment on the proposals.
Release Date: April 22, 2014