Assam Information Portal


Get updates

Guidance on Diagnostic Tests for 2009 H1N1 Influenza Virus

By Assam News on November 2, 2009 at 11:53 pm

The U.S. Food and Drug Administration (FDA) on Monday published a guidance document that should help manufacturers develop diagnostic tests for the 2009 H1N1 influenza virus. Although there are not any FDA-approved or cleared tests that diagnose this specific infection, during this pandemic manufacturers can submit a request to the FDA for an Emergency Use Authorization (EUA). If granted, the EUA will allow the test to be used during the national public health emergency declared by Department of Health and Human Services Secretary Kathleen Sebelius in April. This guidance document outlines what information the FDA recommends that manufacturers include in these EUA requests.

Swine Flu Test

Swine Flu Test

The EUA authority allows the FDA to authorize use of unapproved or uncleared medical products or unapproved or uncleared uses of approved or cleared medical products following a declaration of emergency, when certain criteria are met. The authorization ends when the declaration of emergency is terminated or the authorization is revoked by the FDA.

While the FDA encourages manufacturers to submit appropriate premarket applications for these tests, the agency also recognizes that it may not be possible to generate complete clinical validation data that would normally be included in an application. However, this guidance outlines information the FDA recommends be included, and the FDA gives these requests thorough and careful review to protect the public health.

During this declared public health emergency, manufacturers of 2009 H1N1 influenza virus tests that are unable to submit a complete premarket notification may use the guidance to submit a request for an EUA.

The guidance document is part of the FDA’s ongoing efforts to provide public health authorities managing the pandemic with reliable and accessible diagnostic tests. The guidance is available online at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM188679.pdf, and will remain in effect throughout the public health emergency.



Share |

Category: Health and Fitness | Tags: , , , , , ,

SUBSCRIBE TO OUR LATEST NEWS HEADLINES VIA EMAIL

ENTER YOUR E-MAIL ADDRESS:

Leave a Reply

SPECIAL FEATURES

Health and Fitness

HEALTH TIPS
Health and Fitness News and Tips.

Science

SCIENCE NEWS
Latest Science News just for You.

Photo Gallery

PHOTO GALLERY
Photo Galleries of Models and Celebrities.

Latest Articles

More Articles

Guide for Purchasing Perfect Bouquet

If you are getting married soon and want a beautiful bouquet, then here is the ways by which you can make it by yourself. The first thing while making... 

Chile earthquake death toll increases

The 8.8-magnitude earthquake that struck Chile on Saturday left more than 214 people dead. The death toll may rise as hundreds of people were still missing... 

Watch Assamese Videos Online

ASSAMESE VIDEOS Assam Videos: New Assamese VCDs, Bihu Videos, Zubeen Garg Videos, Old Assamese Songs etc.

Some More Articles

Popular Topics