US product categorisation to be transferred to FDA
This article was originally published in Clinica
US Officials at the FDA and the Centers for Disease Control (CDC) are negotiating the transfer of certain responsibilities under the Clinical Laboratory Improvement Amendments of 1988 from the CDC to the FDA.
The responsibilities to be transferred include the categorisation of commercial test systems - mainly in vitro diagnostic devices - into the three levels of complexity - high complexity, moderate complexity and waived status.
These categories determine regulatory requirements under the Clinical Laboratory Improvement Amendments (CLIA). The FDA was initially responsible for categorising test systems, but the CDC took on the task due to lack of funds at the FDA.
The Health Industry Manufacturers Association (HIMA) has been advocating the transfer of responsibility since 1990. Combining the FDA product review functions with the categorisation activities under CLIA - both of which are required prior to marketing an in vitro diagnostic device - is a far more efficient way for the government to do business than the current two-step process, HIMA president Alan Magazine and David Fleming, group senior vice president at Genzyme, said in a July 17 letter to Health and Human Services Secretary, Donna Shalala.
Negotiations between the FDA and the CDC began about a month ago and could take some time. Issues to be decided include transferring staff and lab inspection fees to the FDA, industry officials said last week.