Regulatory Focus™ > News Articles > In Fight Against Ebola, Device Company Seeks FDA Approval Through Rarely Used Pathway

In Fight Against Ebola, Device Company Seeks FDA Approval Through Rarely Used Pathway

Posted 10 April 2015 | By Alexander Gaffney, RAC,

In the battle against the Ebola virus, perhaps no weapons have been as sought after as new treatments and diagnostic products to help keep the virus in check and patients safe from harm. But since the start of the outbreak in 2014, one regulatory standard has been an elusive goal for these medical products: Approval. To date, no product has received the full approval of the US Food and Drug Administration (FDA). Now one company is hoping to change that.

Seeking Approval

On 10 April 2015, Aethlon Medical announced it is seeking FDA approval for its Aethlon Hemopurifier under the agency's Humanitarian Use Device (HUD) pathway. The pathway, which is little known outside of regulatory circles, allows a device to be approved based on an analysis of its safety—not its efficacy—in humans.

For devices accepted for review under the HUD pathway, FDA requires the device be shown to "not expose patients to an unreasonable or significant risk of illness or injury" and demonstrate a "probable benefit to health."

The HUD pathway is only eligible for diseases which affect fewer than 4,000 patients in the US.

Read our extensive regulatory explainer on the HUD pathway here.

Pathways to Use

To date, medical products intended to treat patients with Ebola have only been made available through three regulatory pathways:

A drug or device is the subject of an FDA-approved Investigational New Drug (IND) application or Investigation Device Exemption (IDE) application, which permit a company to conduct a clinical trial
A drug or device has been granted Emergency Use Authorization (EUA) by FDA, which permits a product to be used to treat Ebola for a limited time and under limited conditions. (More on FDA's Emergency Use Authorization program)
An investigational drug or device is made available under FDA's expanded access program—also known as compassionate use—which permits the product to be used in populations for which the drug is not intended. (More on FDA's expanded access program)

However, full approval has been elusive for products intended to treat Ebola. While many products have been used to treat the virus, few have been studied in trials, and few of those trials have been able to collect data which would easily support the approval of a product.

Leveraging the HUD Pathway

That's where Aethlon's HUD strategy comes into play. As explained earlier, HUD applications are designed for small populations and for devices supported by limited amounts of data. In addition, the HUD pathway is only intended for conditions where there "is no comparable device available to treat or diagnose the disease or condition." Because all other devices have been authorized for use—not approved for use—Aethlon can seek approval through this pathway.

If Aethlon's application for its bio-filtration device is accepted for review by FDA, the company should receive an approval decision within 75 days.

However, even if fully approved, there will still be some limitations on the device's use. FDA's regulations require devices approved through the HUD pathway to be used under the supervision of an institutional review board (IRB).

Aethlon has previously reported that its Hemopurifier device is currently available to patients through expanded access provisions. It has not been authorized by FDA under the agency's Emergency Use Authorization (EUA) provisions.

Aethlon Press Release