2011年 5月 27日

House Republicans Propose 12% Cut to FDA Budget

The US House of Representatives’ Appropriations Committee has issued a 2012 spending bill cutting the Food and Drug Administration’s budget by $285 million, or 11.5%.
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2011年 5月 27日

AdvaMed’s Reform Arguments Undermined by its Actions in 1997

Recent investigative reports from The Chicago Tribune call into question US medical device industry arguments...
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2011年 6月 3日

FDA Issues Advisory on Medical Device Components Imported from Japan

The US FDA’s Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER) have issued a notice warning of possible effects the ongoing nuclear disaster in Japan may have on medical device components exported to the US.
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2011年 6月 8日

FDA Inspections Database Now Live

The US Food and Drug Administration’s database of publicly available inspection information has officially launched. The Inspections Database provides information on the compliance status of regulated firms and facilities that must comply with the Food, Drug and Cosmetic Act. Inspection data is classified according to individual firms’ compliance status. Inspection results, from least to most serious, are indicated either as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI).
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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Draft Guidance from FDA on Regulation of Nanotechnology

Draft guidance issued June 9 th by the US Food and Drug Administration lays out possible reg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 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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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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