Tag Archives: FDA Guidance

FDA Issues Guidance for Applying Human Factors and Usability Engineering to Medical Devices to Ensure Safety and Effectiveness

In an effort to assist the medical device industry in maximizing the likelihood that new medical devices will be safe and effective for intended users, the U.S. Food and Drug Administration recently released Guidance for Industry and FDA Staff on Applying Human Factors and Usability Engineering in Medical Devices. While this FDA guidance document does not establish legally enforceable responsibilities for manufacturers, it is the FDA’s intent to support manufacturers in improving the design of medical devices to minimize potential use errors and resulting…

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New FDA Guidelines on Medical Device Mobile Apps

Scores of apps are available in the iTunes Store and the Android equivalent that are related to health and well being. This past week FDA issued a guidance (FDA Guidance for Mobile Apps) for Mobile Medical Applications which provides critical and much needed guidelines for industry as to which mobile medical apps are and are not going to be regulated by FDA as a medical device.  Last Thursday the FDA also engaged in a Twitter chat meeting for a question and answer session…

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5 Billion in R&D for Each New Drug?

Forbes recently estimated that it costs $5 billion for big pharma to bring each new drug to market.  That number is reduced drastically to $350 million per drug if the company is focused solely on bringing one drug to market and not engaging in multiple research projects at a time.  These numbers were calculated based on the SEC filings of 98 companies and how much they spent on R&D compared to the number of FDA approved drugs they brought to market.  These R&D costs encompass…

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