2011年 5月 2日

Updated Guidance from FDA on Reusable Medical Device Labeling Out for Comment

The Food and Drug Administration (FDA) has issued draft guidance on labeling of reusable
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2011年 5月 6日

Final Guidance from FDA on Dispensing Devices Sold with OTC Drugs

The US Food and Drug Administration has published final guidance targeting over-the-counter drug products packaged with syringes, droppers and other dispensing devices.
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2011年 5月 11日

FDA Orders Post-market Studies of Metal-On-Metal Hip Replacement Devices

The US Food and Drug Administration has ordered all manufacturers of “metal-on-metal” artificial hip devices to conduct post-market studies to see whether the implants are malfunctioning or causing health problems in patients.
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2011年 5月 16日

CDRH Steps Up Vigilance of Genetic Testing Product Sector

The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) has issued letters to
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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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