2012年 4月 2日

GAO: FDA Medical Device Review Timeframes Increasing

A new report from the US Government Accountability Office (GAO) provides yet more data showing...
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2012年 3月 27日

US FDA Further Explains its Pilot Program for ISO 13485 Audits

Following last week's announcement that it would implement a pilot program in June waiving FDA GMP quality system inspections for manufacturers choosing to submit recent ISO 13485:2003 audit reports, the US Food and Drug Administration has published additional explanations of how its new program will work.
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2012年 3月 19日

Guidance Released for FDA ISO 13485 Pilot Program

As part of a professed effort to align its regulatory practices more closely with those of Global Harmonization Task Force (GHTF) members, the US Food and Drug Administration is set to implement a
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2012年 3月 2日

CDRH Head: End Substantial Equivalence for Some 510(k) Applications

Center for Devices and Radiological Health (CDRH) director Jeffery Shuren has advocated rejection of 510(k) clearances in instances where applicants’ predicate devices have undergone safety recalls .
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2012年 2月 22日

FDA Explains Electronic Study Data Submission Expectations

New guidance from the US Food and Drug Administration spells out how medical device manufacturers and study sponsors should format
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2012年 2月 10日

New FDA Informed Consent Rules Set for March 2012 Implementation

New informed consent requirements for some medical device clinical trials in the US will go into effect March 7, 2012 .
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2012年 2月 8日

FDA Guidance Tackles Off-Label Information Requests in the Digital Age

Guidance published by the FDA in late 2011 intends to update regulatory requirements for medical device manufacturers responding to
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2012年 1月 26日

CDRH 2012 Strategic Priorities: Familiar Themes

The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) has published its 2012 Strategic Prioritie s, which include improvements to pre- and post-market processes, internal and external communications, and efforts to support innovative product development.
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2012年 1月 10日

GAO Finds FDA Data on Pediatric Devices Lacking

A recent report by the US Government Accountability Office (GAO) finds that the Food and Drug Administration has not consistently taken steps to identify and track medical devices designated for pediatric use .
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2011年 12月 19日

New FDA Guidance Emphasizes Gender Differences in Clinical Studies

New draft guidance from the US Food and Drug Administration recommends improvements to medical device manufacturers’ clinical study designs in order to better assess safety and effectiveness of their products according to gender.
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