Regulatory News In Brief
This article was originally published in The Gray Sheet
Executive Summary
Johnson & Johnson/LifeScan is recalling nearly 2 million blood glucose meters in the U.S. and overseas. Court rules in favor of FDA in Cytori 510(k) substantial equivalence case. More regulatory news.
You may also be interested in...
Industry, FDA Coming Together On Risk Management For Marketed Devices
Online-Only Content >>> Representatives from the device industry and FDA are trying to establish common ground for how to assess and manage risk of potential safety or compliance issues that crop up for marketed devices.
Industry, FDA Coming Together On Risk Management For Marketed Devices
Representatives from the device industry and FDA are trying to establish common ground for how to assess and manage risk of potential safety or compliance issues that crop up for marketed devices.
Industry, FDA Coming Together On Risk Management For Marketed Devices
Representatives from the device industry and FDA are trying to establish common ground for how to assess and manage risk of potential safety or compliance issues that crop up for marketed devices.