FDA Launches Effort To Integrate Ortho Device Registries
This article was originally published in The Gray Sheet
Executive Summary
FDA has organized a small group of stakeholders to map out a plan for an international registry of orthopedic implants to better assess outcomes and safety of the devices. The agency hopes to release a report within the next two months detailing a framework for putting the initiative together, officials said at a May 9 public meeting.
You may also be interested in...
Regulatory News In Brief
FDA issues guidance documents on PMA and 510(k) user fees and refunds. Agency issues proposed order for three pre-amendment devices. More regulatory news.
Washington Roundup, April 2012
The latest medical device regulatory and reimbursement news from Elsevier Business Intelligence’s “The Gray Sheet.” This month we cover CDRH’s plans to expand its Medical Device Epidemiology Network and the potential impact of the JOBS Act on life sciences start-up companies.
Cornell Maps Clinically Meaningful Ortho Device Attributes
An FDA-funded project lead by Cornell researchers will focus on applying information from the International Consortium of Orthopedic Registries “to create a worldwide attribute and characteristic database” for orthopedic devices.