Originally Published IVD Technology November/December 2002
INDUSTRY NEWS
CDRH to open new IVD-only office
) |
|
The current organizational
structure of the Office of Device Evaluation at FDA's Center for Devices
and Radiological Health. The Division of Clinical Laboratory Devices and
its branches will be a part of the new Office for In Vitro Diagnostic
Device Evaluation and Safety.
(click to enlarge) |
FDA's Center for Devices and Radiological Health (CDRH) has announced plans to establish a new office-level organization called the Office for In Vitro Diagnostic Device Evaluation and Safety. The office will implement both structural and functional changes in the way CDRH regulates IVDs, and is designed to consolidate all premarket, compliance, and postmarket IVD regulatory activities into a single unit.
"The structural changes are such that IVD companies will have one-stop shopping so that all IVD issues will come to the same office, as opposed to having three- or four-stop shopping," says Steven Gutman, MD, director of the Division of Clinical Laboratory Devices at CDRH, who has been selected to head the new office. "The functional changes relate toward trying to move away from snapshot reviews to a more global, integrated process in order to take different pieces of the regulatory picture and find synergisms between those pieces."
The new office will operate using a product-line focus, with complete integration of all regulatory oversight for IVDs in a common unit, and building from a common pool of expertise. According to CDRH officials, the goal of the office is to develop a seamless and interactive regulatory process consistent with a total product life-cycle approach.
Industry analysts believe that the new office should improve FDA's efficiency and oversight of IVD products and that sharing of current information between product reviewers and compliance staff will help in focusing their priorities more effectively as a team. Some analysts believe that this office may lead to more IVD enforcement activity.
"IVD reviewers have long complained that IVD enforcement actions seem to assume a low priority compared with other medical specialty areas, as the Office of Compliance usually ranks the risk of IVD noncompliance by manufacturers low compared with other contact medical devices," says Tom Tsakeris, president of Devices & Diagnostics Consulting Group (Rockville, MD). "This may change since proposed compliance actions will now have the full weight of the new IVD office behind them." However, while recognizing what CDRH is hoping to accomplish, other industry analysts are somewhat guarded in their enthusiasm for the new office.
"On its face, it is a good thing that device premarket and postmarket activities are being combined to provide what FDA hopes will be the appropriate level of regulation for IVDs," says Carolyn Jones, associate vice president for technology and regulatory affairs at AdvaMed (Washington, DC). "However, the devil is always in the details. Nevertheless, I do believe that the new office will allow FDA, if it so chooses, to look at IVD issues with a new eye. It is an opportunity for them to think out of the box."
Copyright ©2002 IVD Technology
