2011年 6月 9日

VC Group Lobbies for Reforms to US Medical Device Review Process

The Medical Device Venture Council, an informal group of venture capitalist firms focused on life sciences investing, has undertaken efforts to convince US lawmakers and Obama Administration offici
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2011年 6月 13日

Draft Guidance from FDA on Regulation of Nanotechnology

Draft guidance issued June 9 th by the US Food and Drug Administration lays out possible reg
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2011年 7月 15日

AdvaMed Study: Competition Keeping US Medical Device Pricing Low

A new study by US medical device industry lobbying group Advanced Medical Technology Association (AdvaMed) finds that prices for medical devices and diagnostic products have increased at less than one-fourth the rate of other medical products and services due to high pricing competition.
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2011年 7月 12日

FDA Proposes Exempting Some In Vitro Devices from 510(k) Review

New draft guidance from the US Food and Drug Administration would reclassify some in vitro...
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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Draft Guidance on Human Factors and Usability Engineering Issued by FDA

The US Food and Drug Administration (FDA) has published a 37-page draft guidance for industry on proper human factors testing and medical device design optimization.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 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 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 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 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 14日

FDA Proposes CDRH Restructuring, Bigger Budget to Meet MDUFA III Requirements

The US Food and Drug Administration (FDA) has floated the possibility of reorganizing the Center for Devices and Radiological Health (CDRH) and providing more resources to the branch in order to ad
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