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Premarket exemption final rule

This article was originally published in The Gray Sheet

Executive Summary

Effective Feb. 14, rule lists all Class I and Class II devices that are exempted from premarket notification under the 1997 FDA Modernization Act. List includes cardiopulmonary bypass accessory equipment and electrode cables, devices which initially had been removed from the list following an FDA proposed rule reclassifying them to Class II and requiring them to meet certain performance standards (1"The Gray Sheet" Nov. 16, 1998, p. 10). The agency explains that as long as these devices met the standard there was no need for them to submit a 510(k), and clarified that this decision would have no effect on the proposed reclassification. On its own initiative, the agency also has added all versions of keratoscopes to the list; previously, keratoscopes using computer software were not considered exempt
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