As medical device quality assurance and regulatory affairs professionals, it can be challenging to stay on top of changes happening in our industry. Few people have the time to read lengthy articles these days and although many online newsletters exist, they are often packed with PR releases, ads or unrelated information. That is why we started this blog for QA/RA professionals in the medical device and IVD industry. The idea is to give you short updates on quality and regulatory topics that may be of interest to you.

2011年 6月 15日

New OJEC Standards, Notified Body Code of Conduct & e-Labeling

Several initiatives to improve the business and regulatory environments in the EU medical device sector...
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2011年 6月 16日

CDRH Audit: Majority of NSE Determinations Due to Inadequate Performance Data from Sponsors

A recent audit of the Food and Drug Administration’s 510(k) program by the Center for Devices and Radiological Health (CDRH) has found that inadequate device performance data submissions from sponsors make up a substantial majority--80%--of Not Substantially Equivalent (NSE) determinations made by the agency between 2005 and 2010. The analysis covered more than 700 NSE determinations made during the course of that six-year period. NSE determinations were based either on failure to provide appropriate performance data to support substantial equivalence (SE) determinations, or to demonstrate equivalent performance compared to predicate devices.
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2011年 6月 17日

CDRH Takes More Proactive Approach with Notice to Industry Letters

The FDA’s Center for Devices and Radiological Health (CDRH) has published a
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2011年 6月 20日

FDA Rolls Out Global Strategy to Oversee Imports

The US Food and Drug Administration (FDA) has launched a new strategy detailed in a new report, the Pathway to Global Product Safety and Quality , to better monitor increasing numbers of imported medical devices and other regulated products hitting the US market. The report calls for a more global approach to regulation of products that fall under the FDA’s purview, recommending four initiatives to carry out the new strategy:
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2011年 6月 23日

FDA’s Medical Device Recall Process Under Fire from GAO

A new report from the US Government Accountability Office (GAO) has found that the Food and Drug Administration (FDA) has not consistently analy
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2011年 6月 23日

Australia, New Zealand to Establish Joint Medical Device Regulator

The governments of Australia and New Zealand are setting up a single regulatory body to oversee therapeutic goods including medical devices and pharmaceuticals across both their countries.
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2011年 6月 23日

Device Recall Regulations Set to Take Effect in China

China’s State Food and Drug Administration (SFDA) will implement new medical device recall regulations on July 1.
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2011年 6月 24日

Draft Guidance on Human Factors and Usability Engineering Issued by FDA

The US Food and Drug Administration (FDA) has published a 37-page draft guidance for industry on proper human factors testing and medical device design optimization.
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2011年 6月 29日

IBM Survey Finds Growing Consumer Demand for Mobile Health Devices

A new survey by the IBM Institute for Business Value indicates high satisfaction rates among patients and caregivers using mobile medical devices, as well as growing willingness to spend money for such devices.
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2011年 7月 1日

Health Canada Elaborates on IEC 60601-1 Compliance Recommendations

Health Canada has provided recommendations for medical device manufacturers whose products must comply with the latest iteration (Third Edition) of the IEC 60601-1 medical electrical equipment safe
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