Device Industry Raises Cost Concerns For Planned Labeling Repository

The device industry recently raised concerns that a proposed labeling repository and database of photographs for 510(k) cleared technologies would be too costly for both the agency and product sponsors, especially due to the tough economic and budgetary environment. However, an FDA official contends that the agency aims to keep costs to manufacturers minimal.

Brian Connell, director of state and federal government relations at the Medical Imaging and Technology Alliance, raised concerns about the costs associated with implementing a device labeling repository because it would necessitate an enormous research burden on agency staff, particularly if such information has to be screened for every cleared product. “MITA remains extremely concerned that FDA is not currently resourced to design, establish or maintain a repository,” he said at an FDA workshop on the initiative. “This effort will require substantial time and effort for both manufacturers and for FDA.” He said FDA should instead focus its resources on product approval and clearance efforts.

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