2012年 7月 10日

US MDUFA Changes Signed into Law (Finally)

( Update: The following blog entry was revised on July 23, 2012 to reflect the most recent fee schedule in place at the FDA.) The Medical Device User Fee Amendments of 2012 (MDUFA III) providing increased funding for the US Food and Drug Administration have been signed into law as part of the FDA Safety and Innovation Act (FDASIA) by President Obama following months of intense negotiations between medical device industry and regulatory representatives.
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2012年 6月 22日

FDA Guidance would Reclassify Implanted Blood Access Devices to Class II (Special Controls)

New draft guidance from the US Food and Drug Administration (FDA) would allow reclassification of implanted blood access devices for hemodialysis procedures to Class II (special controls).
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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 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 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 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 4月 9日

FDA Lists Final Guidance on 513(g) Requests for Information

The US Food and Drug Administration has published final guidance on its process for accepting and responding to 513(g) Requests for Information from medical device manufacturers and sponsors.
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2012年 5月 10日

New FDA Guidance Targets Pediatric Exposure to X-Ray Devices

The US Food and Drug Administration is planning new premarket notification requirements for manufacturers of X-ray
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2012年 5月 22日

FDA Report Slams EU Medical Device Approval Process

A new report issued by the US Food and Drug Administration argues that the European Union's regulatory system fails to ensure safety of high-risk medical devices it approves .
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2012年 6月 7日

CDRH Process for Resolving Internal Medical Device Review Disagreements Needs Improving

Processes in place to resolve scientific disagreements among FDA medical device reviewers need stronger definitions and clearer lines of responsibility, according to the US Health and Human Service
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