Medical device tracking
This article was originally published in The Gray Sheet
Executive Summary
Comments are due July 24 on an April 25 proposed rule implementing changes to the medical device tracking regulations as mandated by the FDA Modernization Act. The 1997 law allows patients with tracked devices to refuse permission to release identifying information for tracking purposes. The rule estimates that the cost to industry of maintaining tracking systems will increase from $40 mil. in 1999 to $71 mil. in 2006
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...
Mustang Bio Enters Race For CAR-T In Autoimmune Disease
The biotech company’s CEO talked to Scrip about plans to bring the CD20-targeting CAR-T MB-106 into an investigator-sponsored Phase I trial later this year.