The US Food and Drug Administration (FDA) has formally granted clearance to a testing device intended to be used to diagnose patients with the Ebola virus under special, emergency circumstances.
Background
In March 2013, FDA was given a host of new authorities and responsibilities under the Pandemic and All-Hazards Preparedness Reauthorization Act ( PAHPRA), a piece of legislation meant to bolster the government's ability to respond to health crises, and especially those of a biological nature.
Among the law's many provisions is one that allows FDA to temporarily authorize a medical product ("Emergency Use Authorization") if it determines that an emergency is likely to occur—a "threat justifying emergency authorized use," to quote the legislation. That is a big change from prior legislation, which required a finding that such an emergency already existed in the US, and left little time for proactive efforts.
The law also allows FDA to authorize those products without first ensuring that they meet current good manufacturing practice (CGMP) regulations, which makes it easier to bring products to market without the usual regulatory burdens.
Since the law's March 2013 passage, FDA has approved a small handful of medical products—all diagnostic tests intended to allow health officials to diagnose emerging diseases like the H7N9 influenza virus and the Middle East Coronavirus (MERS CoV).
Ebola Applications
But in August 2014, in the face of a burgeoning outbreak of Ebola Zaire, a hemorrhagic fever, across West Africa, the US government for the first time used its authority under PAHPRA to start preparing for Ebola.
On 5 August 2014, the US Department of Health and Human Services (DHHS) announced that it had determined that "the Ebola virus presents a material threat against the US population sufficient to affect national security," thereby allowing FDA to authorize the use of a diagnostic device for Ebola Zaire, the Department of Defense's EZ1 Real-Time RT-PCR Assay ("TaqMan").
While FDA granted de-facto approval to the device immediately in a letter to the Department of the Army's Division of Regulated Activities and Compliance, it has now granted formal emergency authorization to the same device through the Federal Register.
In an announcement on 16 September 2014, FDA said the authorization will "help assure that medical countermeasures may be used in emergencies to diagnose, treat, or prevent serious or life-threatening diseases."
There are "no adequate, approved [or] available alternative" devices to detect Ebola, FDA noted, saying that the "totality of the scientific evidence available to FDA" supports the emergency authorization of the Army's TaqMan Assay.
As a condition of authorization, the device must be distributed along with a "Fact sheet" for healthcare providers and patients, but will be exempt from CGMP manufacturing standards and other labeling requirements ordinarily mandated for FDA-approved or –cleared devices. The Army will, however, be required to report adverse events to FDA and report false positive and false negative results as well.
FDA Federal Register Notice