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Medical Device Communiqué: 4Q - 2009
FDA Extends CRADA with Kaplan EduNeering until 2014
On October 29, Kaplan EduNeering and the US Food and Drug Administration (FDA) announced they they have extended their Cooperative Research and Development Agreement (CRADA) for five additional years.
The new extension will expand the learning resources of the Office of Regulatory Affairs' virtual university, known as ORA U, which Kaplan EduNeering and FDA originally co-developed in 1999, to train the agency's food, drug and medical device investigators.
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Are Med Device Companies Putting the AdvaMed Code into Effect? View Survey Results from AdvaMed Conference
At the recent AdvaMed Conference, a panel discussion hosted by Kaplan EduNeering asked attendees to share best practices for putting the AdvaMed Code of Ethics into effect within their organizations. The responses from the 40+ session attendees were captured in real-time by an audience response system and are available on our website.
For example, nearly 40% of participants provided training to their contractors, agents, distributors and other third-party manufacturers, and their approaches and expectations varied widely, while 60% have not yet tackled the issue of downstream training.
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New FDA-Authored Course: Medical Device Reporting Overview
As reported by FDANews last week, devicemakers may see action taken on late and incomplete medical device reports (MDRs) as the FDA's Center for Devices and Radiological Health (CDRH) develops a protocol addressing concerns raised in a new report by the HHS Office of Inspector General (OIG). The OIG has been critical of CDRH's review of MDRs, noting it is not using the reports in a systematic manner to address safety concerns about devices.
The FDA has authored a new online course, MDR Overview and General Provisions (Code: FDA63), which is now available through our FDA Inspection and Enforcement library. The MDR regulation provides one mechanism for the Food and Drug Administration (FDA) and manufacturers to identify and monitor significant adverse events involving medical devices. The goal of the regulation is to detect and correct product problems in a timely manner.
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