IVD Technology Magazine
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Originally published January, 1998

IVD Technology News

DCLD to post reclassification list on Web

Diagnostics manufacturers should be watching the Web site of FDA's Center for Devices and Radiological Health (http://www.fda.gov/cdrh) for a new list of IVD product classifications.

According to Steve Gutman, director of the Division of Clinical Laboratory Devices (DCLD) at FDA's Office of Device Evaluation, the list is expected to be posted on the Web site "early in 1998."

Addressing a Barnett International conference on "Clinical Development for IVDs" in December by speakerphone, Gutman said that DCLD had been reviewing all Class I and Class II IVDs with an eye toward reclassifying many products. That effort was helped by the November passage of the FDA Modernization Act of 1997, which exempts manufacturers from having to file premarket notifications (510(k)s) for most Class I products.

DCLD's approach is to "allow most Class I devices to be down-classified to exemptions," Gutman said. "But there will be some exemptions to the exemptions—that is, reserved products that will not be exempted from 510(k) requirements." The modernization act permits the agency to require 510(k) submissions for Class I products if they are intended for a use that is of substantial importance in preventing impairment of human health, or if they present a potential unreasonable risk of illness or injury.

Noting that reclassification could have a significant effect on how manufacturers must handle their future premarket submissions, Gutman urged the audience to look over the new list carefully and submit comments to the agency.