2011年 11月 15日

FDA Seeking Comment on Device Reclassification Policy

Public comment is being requested through January 13, 2012 by the US Food and Drug Administration regarding data collection requirements for
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2011年 11月 14日

FDA Clarifies IDE Approval Process

Through new guidance published this month, the US Food and Drug Administration has clarified its review and approval process for its Investigational Device Exemption (IDE) regulations , and has also proposed steps to allow clinical investigations of high-risk medical devices in some instances where IDE approvals have not been finalized.
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2011年 11月 14日

New FDA Guidance on IDEs for Early Feasibility Studies

The US Food and Drug Administration is proposing a new policy for Investigational Device Exemption (IDE) applications for
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2011年 11月 10日

Comment Period Extended for FDA’s Guidance on 510(k) Device Modifications

The US Food and Drug Administration has extended its comment period to November 28, 2011 for guidance the agency issued
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2011年 11月 2日

FDA Seeks Feedback on Device Labeling Requirements

The US Food and Drug Administration (FDA) has requested public comment from health care providers until January 3, 2012 on its proposed
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2011年 11月 1日

PMA Summary Review Database Now Available from CDRH

The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) has launched a new searc
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2011年 10月 26日

Venture Capitalists Lobbying Congress Heavily to Reign in FDA

Venture capitalists are spending significantly on efforts to lobby the US Congress to ease FDA regulatory requirements for medical device manufacturers, to considerable effect. According to a New York Times report, venture capital funds allocating to medical device and technology manufacturers have provided more than $3.3 million in political donations to lawmakers and political action committees over the past five years.
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2011年 10月 24日

US Device Manufacturers Feeling Price Pressure from Hospitals

Medical device manufacturers in the US market are reporting mounting pressure to lower product prices as clients such as hospital groups seek to lower procurement costs and stem operating losses. According to a survey by hospital group purchasing organization Premier Inc. (via Dow Jones Newswire), hospitals have lost more than $1 billion due to high-cost medical devices and have indicated interest in purchasing lower-cost alternative products in the future.
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2011年 10月 18日

FDA Plans Reclassifying External Pacemaker Pulse Generators to Class II

The US Food and Drug Administration may reclassify external pacemaker pulse generators fr
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2011年 10月 14日

US Senate Bill Targets FDA’s Device Review Process

US medical device industry lobbying efforts against current regulatory practices appear to be working.
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