Regulatory News In Brief
This article was originally published in The Gray Sheet
Executive Summary
FDA issues draft-guidance on accreditation of third-party reviewers for 510(k)s and final guidance for surgical ablation devices. More regulatory news.
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The draft guidance will serve as a user’s guide to the soon-to-be-released unique device identifier database, providing definitions for the device elements and attributes that companies have to submit to the database.
As GHTF Ends, Industry Cautiously Optimistic On Future Harmonization Progress Under IMDRF
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.
FDA’s UDI Draft Rule Details Device Marking, Database Submission Mandates
The long-anticipated proposal maps out a unique device identifier system that FDA says will be crucial to the future of post-market safety surveillance, recall management and safety alerts. The effort also will help reduce medical errors and bring an array of other benefits, stakeholders say.