|
|
|
|
Regulators scanning the
digital scanners
|
Karen Titus
A recent panel on whole-slide imaging launched a clear message from the Food and Drug Administration: The agency views WSI systems as Class III medical devices and plans to regulate them as such.
Gentlemen, start your turtles.
While the FDA’s decision was clear, the next steps are anything but. Vendors, pathologists, the FDA, and the Centers for Medicare and Medicaid Services could head in any number of directions next, but they won’t be moving swiftly. In fact, those who were at the meeting are still dissecting the information presented at the panel, as if Alan Greenspan had delivered one of his famously tortured pronouncements from the Federal Reserve.
|
|
|
Of the FDA’s decision to regulate whole-slide imaging systems as Class III devices, Aperio president Dirk Soenksen says, “They’ve made up their mind.... You’re talking five years at the earliest when someone’s going to get approval.” How broad will Aperio's submission be? “As broad as FDA allows,” he says.
|
Depending on one’s view, the news will slow efforts to bring WSI for primary diagnosis into U.S. laboratories, with some vendors looking to Europe for regulatory relief; have virtually no impact on large vendors, who, while not necessarily enamored of the FDA’s decision, concede it’s one they can live with; kill the market completely; choke innovation among vendors, especially component makers; possibly put laboratories in jeopardy if they try to validate these systems as laboratory-developed tests under CLIA; or encourage laboratories to use WSI for other, already approved purposes, readying themselves for the inevitable day when whole-slide imaging transforms surgical pathology.
[more]
|
|
|
|
|
|
|
|
MORE INFORMATION
|
NOT A SUBSCRIBER?
|
|
For more information about our digital edition, please access our Frequently Asked Questions page.
|
Access our online form to request your complimentary CAP TODAY magazine subscription. Stay informed on emerging issues through feature articles, concise news items, regular columns, and scientific abstracts. Subscribe or renew now.
|
©2012 CAP TODAY, all rights reserved.
The appearance of advertising in this message is not a CAP guarantee or endorsement of the product or the claims made for the product by the manufacturer. If you wish to be removed from this mailing list, go to http://leda.cap.org/UM/U.asp?B1.421.20085.270426 and you will be removed immediately. Thank you.
|
|
|
|
CAP TODAY, 325 Waukegan Road, Northfield, Illinois 60093
|
|
|
