Regulatory News In Brief
This article was originally published in The Gray Sheet
Executive Summary
Herpes tests: FDA is amending a 2007 regulation that downclassified herpes simplex virus (HSV) serological assays to Class II to remove any reference to HSV assays other than type 1 and type 2 tests. In 1983, FDA classified the pre-amendment devices as Class III, then downclassified type 1 and type 2 tests in 2007 (1"The Gray Sheet" Jan. 16, 2006). Other HSV serological tests remained Class III, but because there are no other types of HSV tests on the market, FDA issued the Aug. 25 rule to prevent confusion. HSV assays were one of 27 types of pre-amendment devices that FDA had yet to downclassify or require PMAs for (2"The Gray Sheet" April 13, 2009). HSV test makers include Quest Diagnostics and Bio-Rad
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Regulatory News In Brief
CDRH inspections database: Center launches 1database Sept. 30 of CDRH-led medical device inspections from 2008 to present. Inspections handled primarily by the Office of Regulatory Affairs are not included in the searchable database, so the database provides access to about 25% of device inspections conducted in the past two years. CDRH leads inspections of foreign facilities, as well as inspections related to Medical Device Reporting, labeling and software issues. The database can be found on the CDRH Transparency website. Clinical trial inspections are not included "because information about new medical device development is confidential," CDRH notes
Regulatory News In Brief
CDRH inspections database: Center launches 1database Sept. 30 of CDRH-led medical device inspections from 2008 to present. Inspections handled primarily by the Office of Regulatory Affairs are not included in the searchable database, so the database provides access to about 25% of device inspections conducted in the past two years. CDRH leads inspections of foreign facilities, as well as inspections related to Medical Device Reporting, labeling and software issues. The database can be found on the CDRH Transparency website. Clinical trial inspections are not included "because information about new medical device development is confidential," CDRH notes
Regulatory News In Brief
Pandemic flu test: FDA granted emergency use authorization July 24 to a third diagnostic test for detecting the HINI pandemic flu virus, Quest Diagnostics Focus Diagnostics Influenza H1N1 (2009) real-time reverse transcription polymerase chain reaction test. The authorization, enabled by the 2004 Project BioShield law, permits Quest to distribute the test to clinical labs from its California-based Focus Diagnostics subsidiary. The assay can amplify viral genetic material obtained from nose or throat swabs, or nasal discharges, in patients with symptoms of respiratory infection. The previous two EUA tests were developed by the federal government