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 1月 19日

FDA Unveils Some Elements of 510(k) Overhaul, Postpones Hot-button Issues

The US Food and Drug Administration (FDA) has rolled out some — but not all — long-awaited changes to its 510(k) premarket notification process for clearing moderate-risk medical devices.
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2011年 1月 19日

FDA Reveals Some of its 510(k) Reforms

The US Food and Drug Administration (FDA) has rolled out the 510(k) premarket notification process...
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2011年 1月 20日

CDRH Rolls Out 2011 Priorities

On the heels of revealing some of its 510(k) reform plans on January 19, the...
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2011年 1月 21日

Report: US Reimbursement System Hinders Novel Diagnostics Development

The current US reimbursement system has slowed development and adoption of novel diagnostic devices ,...
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2011年 1月 21日

European Union Regulatory Update

The European Union’s regulatory community appears to be a flurry of activity with new MEDDEV guidance, updated standards lists, and a newly released roadmap for the much anticipated recast.
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2011年 1月 25日

FDA Intends to Require PMAs for Some Defibrillator Products

Manufacturers of automated external defibrillators (AEDs) will likely have to begin submitting premarket approval (PMA) applications for their products in the US based on rumblings at the Food and Dru
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2011年 1月 27日

HC Clarifies Significant Change Guidance

Health Canada has published new guidance defining when manufacturers’ altering of their Class III and Class IV devices constitutes “significant change,” affecting
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2011年 1月 28日

AdvaMed-sponsored Study: FDA Less Efficient than EU Regulators

A new study sponsored by the US medical device industry trade association Advanced Medical Technology Association (AdvaMed), “EU Medical Device Approval Safety Assessment,” has found that the European regulatory system has performed just as effectively in terms of public safety as the US Food and Drug Administration while simultaneously providing a speedier and more efficient path to market for manufacturers.
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2011年 1月 31日

FDA Panel: ECT Devices Require Further Testing

The US Food and Drug Administration’s Neurological Devices Advisory Committee came out last week in support of further testing of devices used in electroconvulsive therapy (ECT). ECT devices used i
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2011年 2月 2日

Canada’s MDB Struggled to Meet Market Authorization Timelines in 2010

According to MEDEC, the Canadian medical device industry trade association, Health Canada’s Medical Devices Bureau (MDB) faced a persistent backlog last year when it came to processing
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