In This Issue...
FDA Authorizes Emergency Use of Quidel’s Avian Influenza Assay
On February 14, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization for Quidel's Lyra Influenza A Subtype H7N9 assay, a real-time reverse transcriptase PCR (rRT-PCR) test for the qualitative detection and differentiation of avian influenza A (H7N9) virus. This assay is only authorized for use after a patient's nasal or nasopharyngeal swab specimen has tested positive for influenza A viral RNA by using a FDA-cleared influenza A device, and has been deemed "un-subtypable" by using FDA-cleared influenza devices with subtyping capabilities for all currently circulating influenza A viruses in the U.S. The scope of this authorization is also limited to use of the Lyra assay in conjunction with nucleic acid extraction on the FDA-cleared bioMérieux NucliSENS easyMAG system, followed by rRT-PCR on the FDA-cleared Applied Biosystems 7500 Fast Dx Real-Time PCR instrument.
Healthcare workers first detected H7N9 in China in 2013. Shortly afterward, Department of Health and Human Services Secretary Kathleen Sebelius determined that H7N9 could pose a significant threat to public health and that these circumstances justify the authorization of emergency use of in vitro diagnostics for detection of the H7N9 virus.
Final Rule Released on Postmarket Medical Device Reporting
FDA has published its final rule on the new electronic submission requirements for postmarket medical device reporting. Effective August 14, 2015, this rule will require device manufacturers and importers to submit medical device reports (MDRs) of individual medical device adverse events in an electronic format that FDA can process, review, and archive. This includes reports of deaths, serious injuries, and malfunctions that must be reported to FDA in initial 5-, 10-, or 30-day individual MDRs as well as information that must be reported to the agency in supplemental or follow-up reports. The final rule only changes the manner in which these reports are submitted, though, with the underlying reporting requirements staying the same.
Previously, FDA accepted both paper and electronic MDRs, but decided to institute mandatory electronic reporting in order to improve the agency’s process for collecting and analyzing postmarket medical device adverse event information. User facilities are one exception to this change—although they can submit electronic MDRs, they are still permitted to submit written MDRs as well.
To submit electronic MDRs, manufacturers and importers can use either FDA eSubmitter or Health Level 7 Individual Case Safety Reports.
For the full rule, "Medical Device Reporting: Electronic Submission Requirements," please visit www.federalregister.gov.
Biofortuna’s HLA Typing Kits Receive FDA Clearance
FDA has cleared Biofortuna's line of SSPGo HLA PCR kits for the qualitative determination of human leukocyte antigen alleles in low-to-intermediate resolution. These kits are designed for transplantation genotyping and identifying genes that may be associated with various genetic conditions. They contain a freeze dried mix of all the reagents necessary for PCR, including Taq polymerase, to which the user can add DNA prior to amplification and detection. Additionally, the kits are stable at ambient temperature, eliminating the need for temperature-controlled shipping, and for storage in a refrigerator or freezer.
FDA Grants CLIA Waiver to RPS for Rapid Dry Eye Disease Test
Rapid Pathogen Screening (RPS) has received a Clinical Laboratory Improvement Amendments (CLIA) waiver from FDA for InflammaDry, the company's rapid, disposable, point-of-care test for the diagnosis of dry eye disease. This waiver allows the InflammaDry test to be used throughout the U.S. by any medical personnel in healthcare facilities with a CLIA Certificate of Waiver. Using a small sample of tears from the patient, the test detects elevated levels of the inflammatory marker matrix metalloproteinase 9 in less than 2 minutes. Then after 10 minutes, the test displays a blue control line for a negative result, or blue and red lines for a positive result.