John Sheets Takes Over at ODE
Industry veteran John Sheets has been appointed as the new director of the FDA’s Office of Device Evaluation, which is responsible for premarket review of devices.
Sheets, who began his new duties on June 12. Previously he was the chief scientific officer at device and biotech firm Anika Therapeutics.
William Maisel had served as acting director of ODE since September 2014, in addition to his CDRH deputy director for science duties.
MHRA Updates Quicksite, Quickflex Alert
MHRA has updated a 2012 medical device alert for Quicksite and Quickflex devices manufactured by St. Jude Medical, recommending discontinuation of prophylactic replacement.
Certain models with damaged lead insulation could potentially worsen heart failure symptoms after implantation.
MHRA recommends that cardiologists and cardiac physiologists return patients to a six- month follow-up period, and withdraw certain models and remotely monitor patients in collaboration with St. Jude.
The April 2012 alert advised UK hospitals not to implant QuickSite and QuickFlex leads, and to follow up every three months on all patients already implanted with these leads.
Read the updated alert here: www.fdanews.com/06-23-16-MHRALeadAlert.pdf.
Hologic’s Zika Virus Assay Scores EUA
has won an emergency use authorization from the FDA for its Aptima diagnostic to detect Zika virus.
The Aptima assay detects Zika RNA in human serum and plasma. The molecular diagnostic tool runs on the Hologic Panther system.
Under the EUA, the Aptima assay is exempt from GMP requirements as well as labeling requirements for cleared, approved and investigational devices.
The emergency use authorization sets certain reporting and documentation requirements on Hologic and its distributors. It also requires that the assay be available only in authorized laboratories.
FDA Approves Procleix Zika Assay
The FDA has approved the Procleix Zika virus screening assay using the Procleix Panther System to screen donated blood in potential endemic areas of the U.S. under an IND.
Co-developed by Hologic and Grifols, the Procleix Panther system automates nucleic acid testing (NAT)-based blood screening on a single, integrated platform, eliminating the need for batch processing.
The American Red Cross will participate in the Procleix Zika Virus assay investigational study, which will begin testing donated blood for Zika virus early this summer to ensure patients receive safe blood transfusions in targeted endemic areas.