Washers For Reusable Devices Should Fall Into Class II, Panel Recommends
This article was originally published in The Gray Sheet
Executive Summary
All previously unclassified washers and washer-disinfectors intended for processing reusable medical devices should be formally grouped under Class II for premarket notification submissions, FDA's General Hospital and Personal Use Devices Panel recommended at its Sept. 14 meeting.
You may also be interested in...
FDA Regulatory News In Brief
Device tracking: 1Medical device tracking final rule amending 1993 reg to reflect changes under FDAMA is effective May 9. No revisions are made to the April 25, 2000 proposed rule (2"The Gray Sheet" May 1, 2000, In Brief). The rule "makes no revisions to the regulation's existing system and content tracking requirements, the current obligations of persons other than device manufacturers, such as distributors, records and inspection requirements and existing record retention requirements." A final guidance on medical device tracking was issued Jan. 24, 2000...
New EU Approvals
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add two new products, including Ryzneuta, Evive Biotechnology's treatment for chemotherapy-induced neutropenia.