INDUSTRY NEWS
FDA has released draft guidance describing how herpes simplex virus types 1 and 2 (HSV 1 and HSV 2) assays can comply with special-controls requirements for Class II devices. The report was published to support FDA’s proposal to reclassify the tests from Class III to Class II devices. “The effectiveness of HSV 1 and/or 2 serological assays has been well established over the past 25 years,” wrote the Center for Devices and Radiological Health in a January 9 Federal Register notice filed by Linda S. Kahan, deputy director of the center. “Technological improvements have increased the reliability and performance of these devices for clinical sensitivity and specificity.” A 1980 proposed rule to make types 1 and 2 HSV tests Class II devices was ultimately rejected due to concerns that inaccurate identification of the virus or its antibodies could lead to serious health risks in newborn infants.
Assays for HSV infections other than HSV types 1 and 2 will still be considered Class III devices. The report does not cover nucleic acid–amplification assays. The draft guidance document can be accessed online at www.fda.gov/cdrh/oivd/guidance/1305.pdf.
Roche Diagnostics (Basel, Switzerland) has announced that, effective January 1, CEO Heino von Prondzynski has retired from his position at the company. Von Prondzynski had served as head of Roche’s diagnostics division since February 2000. Before joining the company, he worked at Bayer and Chiron Corp.
Severin Schwan, regional head of Roche Diagnostics’ Asia-Pacific business, has been appointed by the board of directors to replace von Prondzynski. Schwan joined Roche in 1993 and has held a number of corporate and global finance positions during his tenure.
