Downclassification Of Six Cardiovascular Devices To Class II Delayed
This article was originally published in The Gray Sheet
Executive Summary
FDA is postponing the downclassification from Class III to Class II of six cardiovascular devices pending receipt of public comments on guidance documents intended to serve as special controls for the devices.
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FDA guidances
Comments are due by July 18 on guidance documents for 510(k) submissions for permanent pacemaker leads, vascular prostheses, annuloplasty rings, extracorporeal blood circuit defoamers, cardiopulmonary bypass arterial line blood filters and oxygenators. The six devices were among 38 preamendments devices slated for reclassification from Class III to Class II in a March 15, 1999 proposed rule. Reclassification of the six devices has been put on hold, however, until the guidance documents are finalized (1"The Gray Sheet" June 28, 1999, p. 21)
FDA guidances
Comments are due by July 18 on guidance documents for 510(k) submissions for permanent pacemaker leads, vascular prostheses, annuloplasty rings, extracorporeal blood circuit defoamers, cardiopulmonary bypass arterial line blood filters and oxygenators. The six devices were among 38 preamendments devices slated for reclassification from Class III to Class II in a March 15, 1999 proposed rule. Reclassification of the six devices has been put on hold, however, until the guidance documents are finalized (1"The Gray Sheet" June 28, 1999, p. 21)
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