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Several medical devices use either off-the-shelf or custom software. A couple of guidance documents from FDA written almost a decade ago are the only official comments from FDA to assist manufacturers understand the current FDA requirements. Despite a long history of software usages in medical devices, there is significant confusion regarding updating software applications in new 510(k) devices and the additional testing requirements. The level of details expected in a 510(k) application is very different from what used to be 10 years ago. This webinar will discuss the structure and level of detail required in filing a 510(k) when a medical device is software or contains software.

"The 'Global Fructooligosaccharide (FOS) Market Outlook 2018-2023' offers detailed coverage of fructooligosaccharide industry and presents main market trends. The market research gives historical and forecast market size, demand, end-use details, price trends, and company shares of the leading fructooligosaccharide producers to provide exhaustive coverage of the market for fructooligosaccharide. The report segments the market and forecasts its size, by volume and value, on the basis of application, by products, and by geography. The report has been prepared based on an in-depth market analysis with inputs from key industry participants. The global fructooligosaccharide market has been segmented into five major regions, namely, North America (U.S., Canada, and others), Europe (U.K., France, Germany, Russia, and others), Asia-Pacific (China, Japan, India, Australia, and others), South America (Brazil, Argentina, and others), and Middle East & Africa (South Africa, Saudi Arabia, and others). Furthermore, the report also includes an in-depth competitive analysis of the key vendors operating in this market."

The Office of Device Evaluation (ODE) receives approximately 6500 Premarket Notification (5100) submissions every year. Many of these submissions are incomplete or grossly inadequate, as they fail to contain the components necessary to allow substantive review of the submission and inappropriately consume Center resources. As a means to employ more effectively the Center's resources, the FDA has implemented procedures to ensure that 5 10Ks meet a minimum threshold of acceptability; otherwise the Center will refuse to accept the submissions for substantive review.