AdvaMed Device Submissions Workshop In Brief
This article was originally published in The Gray Sheet
Executive Summary
MR compatibility: CDRH's science office plans development of "guidance and standards that will help manufacturers figure out MRI compatibility with devices," CDRH Deputy Director Linda Kahan tells participants at AdvaMed's 14th Annual Device Submissions Workshop June 3-4 in Arlington, Va. MR compatibility "is something that we find has held up applications for products," and the initiative is meant to speed reviews. The Office of Science & Engineering Laboratories (formerly the Office of Science & Technology) was reorganized this year ("1The Gray Sheet" March 15, 2004, p. 8)...
You may also be interested in...
CDRH Science Office Reorganization Eliminates Branches, Focuses On Labs
The device center's Office of Science & Technology is set to unveil organizational changes, following efforts to revamp the office based on internal and external program reviews
Beauty Firms Using AI-Based Tools Could Be Subject To Health Privacy Laws In US States
Using AI-based programs to collect and store consumer information risks running afoul of new health privacy laws cropping up in US states. Lack of federal regulation or guidance on the issue is one of the biggest challenges for beauty firms deploying AI, according to Stacy Marcus, partner at Reed Smith LLP.
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.