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 5月 23日

CDRH: 577 Warning Letter Cites Issued in 2010

The US FDA’s Center for Devices and Radiological Health has released data on warning letter cites regarding manufacturers’ quality system deficiencies in 2010.
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2011年 5月 24日

Another Survey Shows US Regulatory Structure Undermining Innovation

A new survey conducted by Northwestern University and funded by the Institute for Health Technology...
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2011年 5月 25日

FDA Undertaking Long-term Evaluation of How Medical Devices Interact with Other Appliances

The US Food and Drug Administration’s years-long effort to evaluate how medical devices are impacted by electromagnetic waves emitted by microwaves, security scanners and other appliances has been spotlighted in a new report by The Wall Street Journal .
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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 7日

EU Council Backs Current MedTech Legal Framework

The European Union’s Employment, Social Policy, Health and Consumer Affairs Council has issued
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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 10日

Health Canada’s Surveillance Process Found Lacking

Canada’s Office of the Auditor General has found Health Canada’s medical device surveillance and inspection...
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