FDA Finalizes Program to Speed Access to Devices for Gravely Ill Patients

Posted April 15, 2015

The U.S. Food and Drug Administration (FDA) has introduced a program intended to give gravely ill patients earlier access to certain high-risk devices.

Designed to help those with conditions for which no treatments exist, or that are serious or life-threatening, the Expedited Access Pathway (EAP) program is intended both for novel devices and existing technology. It places a strong emphasis on early and ongoing communication between the agency and developers.

"By interacting with sponsors early and often throughout the review process, FDA and sponsors can better identify and address novel scientific issues earlier to expedite both device assessment and premarket review," according to the April 13 final guidance document (PDF) announcing the program.

"In some cases, patients may be willing to assume greater risk for earlier access to a medical device," according to the guidance. Still, the agency said patient safety must remain front and center, and that it would continue to ensure devices are reasonably safe and effective. To that end, the EAP would require less burdensome premarket data collection requirements for device developers, while increasing the number of postmarket requirements.

As part of the program, the agency will work with each developer to create a data development plan specific to the device. That plan will outline what data will be collected in the pre- and postmarket settings.

Only devices subject to premarket approval or de novo requests are eligible for the program. The de novo process applies to low risk products that have been classified as Class III because they were found not substantially equivalent to an existing device. The FDA urged developers of combination products to consult with the agency as early in the design process as possible to determine eligibility.

Fleshing out Pre- vs. Postmarket Data Collection

A separate final guidance document (PDF) released the same day outlines the agency’s policy on balancing pre- and postmarket data collection.

"When making a determination whether it is appropriate to collect certain data in the postmarket setting, rather than premarket, FDA considers, among other factors, the device’s potential impact on public health," according to the document. Even if all of the risks are unknown, factors, including the probable benefits of the device and postmarket controls, can outweigh the uncertainty.

The agency provides a few examples of when postmarket data collection is appropriate, including when there is an urgent public health need, the device is mature technology (i.e., a device type whose risks and benefits are well understood because of prior testing and clinical use), and  when it might be necessary to modify warning, contraindications, and precautions in approved labeling.

In a blog post announcing the guidance documents, Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, underscored the importance of balancing pre- versus postmarket data collection. "We consider this balancing …to be so important that we made it one of our three 2014-2015 strategic priorities, along with strengthening the clinical trial enterprise and providing excellent customer service," he wrote.