By Megan R. Wilson - 06/04/13 10:03 PM EDT
Department of Health and Human Services Secretary Kathleen Sebelius made the designation on Wednesday, allowing the Food and Drug Administration (FDA) to quickly approve testing devices for U.S. citizens living overseas without going through the normal process.
The FDA has used EUAs to approve drugs or devices since 2007 – H1N1, or swine flu in 2009, inspired more than 15 product approvals under the process. The Centers for Disease Control and Prevention gained EUA approval for a device meant to test for H7N9, the avian bird flu, earlier this year.
In March, Congress passed the Pandemic and All-Hazards Preparedness Reauthorization Act and strengthened the policies surrounding emergency health threat designations.
Among other things, it gives federal regulators the ability to approve products ensuring that they follow regulations in place requiring “good manufacturing practices.”
Since last April, MERS-CoV has infected at least 54 individuals, according to the World Health Organization (WHO). In the last month, there have been at least 30 lab-confirmed cases.
Health officials traced the disease back to Jordan, Qatar, Saudi Arabia and the United Arab Emirates.