As medical device quality assurance and regulatory affairs professionals, it can be challenging to stay on top of changes happening in our industry. Few people have the time to read lengthy articles these days and although many online newsletters exist, they are often packed with PR releases, ads or unrelated information. That is why we started this blog for QA/RA professionals in the medical device and IVD industry. The idea is to give you short updates on quality and regulatory topics that may be of interest to you.

2011年 2月 28日

Australia TGA Clarification on IVD Audits

As previously reported, the TGA reformed IVD regulations in 2010 to align with GHTF recommendations,...
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2011年 2月 25日

Obama’s 2012 Budget Includes 4.8% Increase for CDRH

The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) would see an appropriation of $329 million—a 4.8% increase over current levels—in the Obama administration’s proposed 2012 budget. Total CDRH funding would total $395 million, with $66 million from industry user fees, if the administration has its druthers, according to The Gray Sheet .
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2011年 2月 25日

EU: Broad Support for IVDD Revisions

Comments following European Union regulators’ public consultation on proposed revision to Directive 98/79/EC indicate
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2011年 2月 18日

Battle Lines Drawn in Congressional Hearing on FDA Review Process

Business-friendly US lawmakers and the FDA’s Center for Devices and Radiological Health director Dr.
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2011年 2月 17日

Eucomed Proposes Wider Adoption of Remote Cardiac Device Monitoring Tools

European medical device trade association Eucomed has made adoption of technology to remotely monitor implantable cardiac devices a key element of its four recently submitted proposals to the European Commission Innovation Union Strategy's Active and Healthy Ageing Innovation Partnership program.
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2011年 2月 16日

US Congress Wading into FDA Reform Debate

Opponents of the Food and Drug Administration’s reform efforts targeting medical device reviews have a sympathetic ear in Joe Pitts, the Republican congressman from Pennsylvania who now chairs the Hou
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2011年 2月 16日

Certain IVDs Now Subject to Application Audits by Australia’s TGA

The Therapeutic Goods Administration (TGA), Australia’s medical device regulator, has specified which in vitro devices (IVDs) will be required to undergo
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2011年 2月 15日

Recall Study Results Suggest 510(k) Reform Needed

A new study examining high-risk recall rates of medical devices in the US as added weight to contentions that the Food and Drug Administration’s
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2011年 2月 14日

FDA’s New MDDS Rule Finalized

Final rules to expedite medical device data systems’ (MDDS) path to market in the US have been issued<
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2011年 2月 8日

New Program Could Halve PMA Processing Time for Innovative Devices

In an effort to foster development of cutting-edge medical device technologies, the US FDA has proposed a new program,
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