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November 2009

FDA Chooses MasterControl's QMS

MasterControl, a global provider of quality management systems (QMS), is pleased to announce that it has been selected as the QMS software provider for The Food and Drug Administration (FDA). More specifically, The Office of Regulatory Affairs (ORA) within the FDA has contracted with MasterControl through its partner, i4DM. The mission of the Office of Regulatory Affairs is to protect consumers and enhance public health by maximizing compliance of FDA regulated products and minimizing the risk associated with those products. ORA plans to implement MasterControl as its QMS solution throughout all of its various divisions and offices. ORA's field auditors are among those slated to use MasterControl's QMS Software.

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Biologic-Device Combination Products: Jurisdiction

More and more companies are developing combination products for many life threatening and unmet medical needs. One area that holds much promise is the development of tissue engineered products which contain living cells or tissues combined with a device. As with any novel technology, questions regarding what the requirements will be by the regulators to obtain market approval is always an issue. This has been a changing dynamic in other parts of the world but the Food and Drug Administration (FDA) has dealt with these products for some time and has developed a reasonable approach to regulating combination products. This article will focus on the FDA approach to jurisdiction of cell and device combination products.

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Did you know that in the near future medical device companies will be required to submit MDRs electronically? Said requirements will present several challenges, specifically: breaking the habit of the traditional paper-based MDR management that exists in many medical device environments and implementing the conversion from paper to electronic management within the time frame in which the conversion from paper-based to electronic management is expected to occur.
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