Securities regulators of the World Unite

June 19, 2008

The world’s securities regulators — notably the SEC — take steps to increase their oversight of international accounting standards.

A press release issued by the Securities and Exchange Commission announced that the SEC, as well as the European Commission, the Japan Financial Services Agency, and the International Organization of Securities Commissions welcomed an upcoming roundtable to be held by the International Accounting Standards Committee Foundation (IASCF), the parent organization of eponymous board which sets international financial reporting standards.

Source: CFO

Firefox Download Day

June 19, 2008

Version 3.0 of Mozilla’s Firefox web browser hit the web today, and the folks from Mozilla are trying to break the Guinness world record for most downloads. You can participate by downloading the new version before 11:16 PDT — but even if you don’t get in on the opening day action, it’s worth the time to grab the new edition of the best browser available.

Source: Firefox

About 510(k)

June 19, 2008

Section 510(k) of the Food, Drug and Cosmetic Act requires those device manufacturers who must register to notify FDA, at least 90 days in advance, of their intent to market a medical device. This is known as Premarket Notification – also called PMN or 510(k) . It allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories. Thus, “new” devices (not in commercial distribution prior to May 28, 1976) that have not been classified can be properly identified. Specifically, medical device manufacturers are required to submit a premarket notification if they intend to introduce a device into commercial distribution for the first time or reintroduce a device that will be significantly changed or modified to the extent that its safety or effectiveness could be affected. Such change or modification could relate to the design, material, chemical composition, energy source, manufacturing process, or intended use.

Source: FDA

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