Developers of computer-aided detection (CAD) software are frustrated with the slow pace of new product regulatory approvals at the U.S. Food and Drug Administration (FDA). But according to a report published this week in the New York Times, agency scientists are using a recent CAD approval as an example that the FDA's approval process is too hasty.
The Times story cites agency documents in describing a case in which an FDA official went against the recommendation of agency scientists to clear Nashua, NH-based iCAD's SecondLook Digital CAD for mammography software, designed for use with computed radiography mammography systems from Fujifilm Medical Systems USA of Stamford, CT.
The approval came after the official had received a phone call from Rep. Christopher Shays (R-CT) regarding the software's regulatory application, the story states. The article goes on to describe the incident as part of a larger controversy within the agency's Office of Device Evaluation regarding the clearance of new products.
Agency scientists believe that FDA managers have become too lenient with clearances, according to the Times, and that in this case iCAD never had the device tested by "the intended users (i.e., radiologists) under the intended conditions of use."
iCAD received premarket approval (PMA) for the use of SecondLook with Fuji computed radiography mammography in April 2008. CAD software vendors have complained about a dearth of CAD product approvals from the FDA since the agency announced in May 2008 that it would eliminate the requirement that CAD developers use the PMA process, enabling them instead to use the less rigorous 510(k) process.
Related Reading
FDA proposes easier regulatory path for FFDM systems, June 10, 2008
FDA OKs iCAD SecondLook with Fuji FCRm, April 7, 2008
iCAD nets CAD patent, April 1, 2008
Fuji hits FCRm milestone, March 31, 2008
CAD vendors hope FDA hearings will clear approval bottleneck, March 4, 2008
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