FDA Proposes Annual Reporting in Reclassification of Some Devices

March 13, 2009
Manufacturers of automated blood cell separator devices should submit an annual report to the FDA for three consecutive years if their device was not approved through the PMA process, according to a notice in the Federal Register. The FDA is seeking comments on a November 2007 guidance concerning Class II special controls for automated blood cell separator devices operating by centrifugal or filtration separation principle. Comments must be submitted by May 1.
Devices & Diagnostics Letter