Regulatory News In Brief
This article was originally published in The Gray Sheet
International draft guidance on a single-audit program for device facilities is expected out by the end of the month, ECRI weighs in on UDI proposed rule, and more regulatory updates.
You may also be interested in...
FDA’s Neurological Devices panel found that the benefits of the catheter system do not outweigh the risks for the intended expanded use to treat acute ischemic stroke, and that further studies are needed.
FDA amends UDI proposed rule. Comments sought on pre-market approval exemption for custom devices. More regulatory news.
As the Global Harmonization Task Force held its final meeting last week in Tokyo, members of industry met separately to discuss how GHTF’s work will be carried on by the International Medical Device Regulators Forum.