FDA Proposes Fast-Track Approval Process for Some Medical Devices

On Tuesday, FDA proposed a program that would expedite the approval process for certain medical devices that might be particularly beneficial for seriously ill patients who have no other treatment options, Reuters reports.

The agency said that medical devices would qualify for review under the proposed Expedited Access Premarket Approval Application program if they feature innovative technology and offer significant benefits that similar available devices do not provide (Dey/Kelly, Reuters, 4/22).

FDA in a statement noted that the proposed program is "not a new pathway to market" for medical devices but rather a "collaborative approach to facilitate product development" and bring it to the market more quickly (Slabodkin, Health Data Management, 4/23).

Under the EAP program, manufacturers of qualifying medical devices for life-threatening conditions and unmet medical needs would get access to FDA staff earlier to discuss their products. The agency said that facilitating earlier and more frequent contact between manufacturers and FDA officials would allow "earlier access to safe and effective medical devices."

The program resembles another FDA fast-track program for established medical equipment such as wheelchairs and hip implants (AP/Modern Healthcare, 4/22).

According to Reuters, the proposed program is in response to criticisms from policymakers, patient advocacy groups and industry stakeholders that FDA's approval processes for new and helpful medical devices has become lengthy and inefficient.

Comments

Morningstar analyst Debbie Wang said, "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" (Reuters, 4/22).

However, Bradley Thompson -- an attorney at Washington, D.C.-based Epstein Becker Green and an adviser to many medical device companies on various FDA-related issues -- argued that the EAP program's criteria are too tough and that most devices will not qualify for the program.

Thompson said, "Frankly, most medical devices represent incremental improvements," adding, "when the FDA looks at them it characterizes the gains as more modest" (Health Data Management, 4/23).