2012年 12月 18日

Australien, Brasilien, Kanada und die USA planen ein gemeinsames Audit-Programm für Medizinprodukte

Die für Medizinprodukte zuständigen Behörden in Australien, Brasilien, Kanada und den USA haben eine Erklärung zur Zusammenarbeit bei der Entwicklung eines einzigen Audit-Programms für Medizinprodu
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2012年 10月 1日

FDA Urged to Develop Security Plan for Wireless Implantable Medical Devices

The US Government Accountability Office (GAO) has issued recommendations that the Food and Drug Administration develop a comprehensive plan to improve the agency’s ability to review and monitor active implantable medical devices that rely on wireless and other advanced technologies.
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2012年 10月 19日

FDA to Require Electronic Filing of Medical Device Registration Submissions

The US Food and Drug Administration has published guidance outlining its plans for requiring medical device manufacturers to submit registration materials electronically via the agency’s eCopy Program. The eCopy Program is currently voluntary, but will become mandatory upon finalization of the proposed guidance as required by the Food and Drug Administration Safety and Innovation Act signed into law earlier in 2012. Once mandatory, the program will require manufacturers to submit eCopies along with standard application documents in order for the FDA to process and review them. Applications that do not include eCopies of their submissions will be put on hold until applicants provide eCopies.
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2012年 10月 24日

New 510(k) Timeframe and Performance Goals at US FDA

The US Food and Drug Administration has set new review timeframes and performance goals for 510(k) premarket notification reviews of medical devices following Congressional approval of the Medical Device User Fee Amendments of 2012 (MDUFA III) earlier this year. By 2017, the agency intends to reduce the average total time for 510(k) decisions to 124 days from 150 days for fiscal year 2012.
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2012年 12月 11日

FDA Report Claims Improved 510(k), PMA Review Times

The US Food and Drug Administration has published a new report showing small but consistent...
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2012年 12月 13日

New FDA Guidance on Home Use Medical Devices

New guidance published by the US Food and Drug Administration advises manufacturers of “home use” medical devices on how to ensure compliance with safety and effectiveness requirements when designing their products.
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2012年 12月 13日

Australia, Brazil, Canada and US Plan Shared Medical Device Audit Program

The medical device regulators of Australia, Brazil, Canada and the US have all signed on to a statement of cooperation to develop a single audit program for medical devices to be used by all four market authorities. Upon implementation of the MDSAP program, the audit of a medical device manufacturer’s quality system in any one of the four participating countries will meet regulatory requirements of all four countries—a significant move that could ease medical device company’s paths to market in these regions.
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2012年 12月 13日

US FDA Establishment Registration Renewal Deadline Extended

The FDA recently announced that the annual period for medical device establishment registration renewal has...
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2012年 12月 14日

FDA-Bericht: nun schnellere Bearbeitung von 510(k)- und PMA-Anträgen

Die US Food and Drug Administration hat einen neuen Bericht veröffentlicht, in dem geringe, jedoch...
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2012年 12月 18日

Verlängerung der Frist zur Erneuerung der US FDA Betriebsregistrierung

Die FDA hat vor kurzem bekanntgegeben, dass der jährliche Zeitrahmen zur Erneuerung der Betriebsregistrierung für Medizinprodukte um einen Monat verlängert wurde. Der Erneuerungszeitraum für die Registrierung für das Geschäftsjahr 2013 (1. Oktober 2012 bis 30. September 2013) sollte ursprünglich am 31. Dezember 2012 ablaufen. Dank der Verlängerung haben Hersteller nun bis 31. Januar 2013 Zeit, um Ihre Betriebsregistrierung zu verlängern.
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