2011年 3月 11日

FDA Plans 2011 Guidance for Mobile Medical Applications

At a US Food and Drug Administration town hall meeting held March 10 in Irving, TX, Center for Devices and Radiological Health director Dr.
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2011年 3月 16日

FDA Publishes Changes to Premarket Review Standards

Effective March 8, the US FDA has issued modifications to the list of standards used...
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2011年 3月 25日

CDRH Updates Import Entry Review Process for Medical Devices

The US FDA’s Center for Devices and Radiological Health (CDRH) has issued recommendations to improve
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2011年 3月 25日

Important US FDA Import Recommendations

The FDA's Center for Devices and Radiological Health (CDRH) has published a Letter to Industry dated 24 March 2011 outlining information importers should provide to ensure expedited entry of th
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2011年 3月 30日

Expediting Customs Clearance with AofC Codes

The FDA recently issued a Letter to Industry with recommendations for using Affirmation of Compliance (AofC) codes to expedite release of goods from US Customs and Border Protection (CBP) for imported medical devices. Use of the AofC codes is voluntary but recommended to avoid Customs delays. According to informal discussions with the FDA, proper use of AofC codes can reduce the Customs processing time from several days to a matter of minutes. We have listed some of the most commonly used AofC codes here .
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2011年 3月 31日

US Meddev Industry Gaining Congressional Sympathy

In a sign of the US medical device industry’s increasing clout among federal legislators, Senators Scott Brown of Massachusetts and Amy Klobuchar of Minnesota have relaunched the Senate Medical Technology Caucus to drum up Congressional attention on issues such as the 2.3% excise tax and possible changes to the FDA’s 510(k) clearance process.
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2011年 4月 8日

US Government Shutdown Would Hamper FDA Clearance and Approval Process

A potential shutdown of the US government due to Republican lawmakers’ stance on budget negotiations would significantly reduce the Food and Drug Administration’s ability to conduct inspections of foo
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2011年 4月 12日

FDA Weighs Classifying EHRs as Medical Devices

The US Food and Drug Administration (FDA) is considering whether to regulate electronic health records (EHRs) as medical devices as it develops new rules targeting software, according to Center for Devices and Radiological Health (CDRH) director Dr. Jeffrey Shuren.
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2011年 4月 18日

GAO Finds FDA’s Review and Safety Processes Inadequate

In April 13 testimony before the US Senate’s Special Committee on Aging, Government Accountability Office...
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2011年 4月 20日

FDA Grants Six-month Extension for Transition from Steris

The US Food and Drug Administration has allowed a six-month extension to health care facilities...
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