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 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 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 28日

Evolving IVD Regulations in Europe

In Europe, a response was published to public comments on the proposed recast of Directive 98/79/EC.
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2011年 3月 1日

TGA Improves Public Access to Medical Device Registry

The Therapeutic Goods Administration (TGA), Australia’s medical device and pharmaceutical regulator, has set up easier online access to its
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2011年 3月 3日

ISO 14155 Revisions to Substantially Impact Clinical Investigations

The International Organization for Standards (ISO) recently published a revision of its ISO 14155 rule...
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2011年 3月 4日

GHTF Moves to Disband

The Global Harmonization Task Force (GHTF), founded in 1992 to promote uniformity across medical device regulatory regimes, will soon cease to exist
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2011年 3月 9日

FDA Clarifies Malfunction Reporting Requirements

The US Food and Drug Administration (FDA) has issued a clarification regarding medical device manufacturers’ and importers’ compliance with
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2011年 3月 10日

Australian TGA Responses to Public Comments on Proposed Medical Device Regulation Reforms

The TGA has published public comments to the discussion paper, Reforms in the Medical Devices...
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2011年 3月 11日

Global Harmonization Task Force (GHTF) to Reorganize

(Published March 2011)
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2011年 3月 11日

FDA Plans 2011 Guidance for Mobile Medical Applications

At a US Food and Drug Administration town hall meeting held March 10 in Irving, TX, Center for Devices and Radiological Health director Dr.
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