Warning Letter Roundup & Recap – May 19, 2015
This article was originally published in The Gray Sheet
Executive Summary
After evaluating information gathered during an FDA inspection and reviewing ZYTO Technologies' website, the agency discovered that the firm promoted its device for functions outside its cleared intended use; MicroAire had no internal systems for determining whether an event was MDR-reportable; and more. Two warning letters were listed by FDA this week.
You may also be interested in...
Second Warning To Utah Company For Promoting Device Outside Intended Use
The US Food and Drug Administration issued a warning letter to ZYTO Technologies for marketing its Hand Cradle Galvanic Skin Response device for purposes outside the scope of its authorized use.
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.