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.

2009年 4月 9日

US FDA issues notice on preamendment Class III medical devices

The FDA has posted an order in the Federal Register (Thursday, April 9, 2009, Vol. 74, No.
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2009年 4月 9日

US FDA issues notice on preamendment Class III devices

The Food and Drug Administration (FDA) just posted a notice in the April 9, 2009 Federal Register notifying manufacturers of 25 types of Class III medical devices that their products will be subject t
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2009年 5月 1日

US FDA announces new website

The Food and Drug Administration has said that it plans to launch a redesigned website, presumably in 2009. This should be good news for users of the site. Hopefully, guidance documents and other relevant information will be easier to find, and databases will be easier to use. Keep your fingers crossed.
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2009年 5月 8日

US FDA may get large increase in funding

Today the Wall Street Journal published an article noting that President Obama has requested an additional $300,000,000 in funding for the US FDA, from $2.06 billion to $2.35 billion. That's a 14% increase. If the funding is approved by Congress, the agency will likely hire more inspectors which will lead to more frequent visits from the FDA to medical device manufacturers.
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2009年 6月 11日

European Commission issues interpretation of Directive 2007/47/EC

The European Commission has issued an interpretative document (dated 5 June 2009) of Directive 2007/47/EC (which amends the Medical Devices Directive MDD 93/42/EEC and the Active Implantable Medical Devices Directive AIMDD 90/385/EEC).
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2009年 6月 11日

European Commission issues important guidance document on 2007/47/EC

The EU has just released an important guidance document that should be read by every company selling medical devices in Europe.
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2009年 6月 25日

Redesigned US FDA website an improvement

The US FDA recently launched a new website, with a new look and organization.
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2009年 8月 12日

MHRA publishes updated guidance document for clinicals conducted in UK

In July, the MHRA issued an updated guidance document on clinical investigations to be carried out in the UK.
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2009年 8月 13日

Health Canada to require STED format for Class 3/4 medical device submissions

Health Canada just put out an official notice that they are going to require the STED format for most Class 3 and Class 4 medical device license submissions by July 2010.
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2009年 9月 23日

FDA Hosts Public Hearing to Address the Internet and Social Media and how they Relate to Product Regulation

The FDA is holding a public hearing on November 12 and 13, 2009 from 8am to 5pm each day to discuss the increasing challenges that social media and the internet have presented to product regulation. The hearing will be at the National Transportation Safety Board Conference Center in Washington, D.C. In addition to the public meeting, the FDA will also accept comments (electronic and hard copy) until February 28, 2010.
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