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Combination products are therapeutic or diagnostic medical products that combine drugs, devices, and/or biological products with one another. FDA developed a regulation (final rule) on Current Good Manufacturing Practices (CGMP) for combination products that became effective Jul 22, 2013 (21 CFR Part 4). AAMI recently developed a technical information report (TIR) that provides information on how to effectively implement FDA's regulation. The overall goal of the TIR is to aid informed, risk-based decisions in establishing CGMP operating systems that support development, manufacture, premarket regulatory evaluation, and ultimately commercialization of combination products. This article, a result of an discussion with industry and FDA representatives, explores the landscape of combination products, highlights important considerations in developing and seeking marketing clearance for these innovative products, and provides insight on trends in the area.

When the author first started to imagine an issue centered on big data, it felt as if she was Alice falling into the rabbit hole and landing in a wonderland that, layer by stripped away layer, seemed curiouser and curiouser. Big data, a broad term for data so voluminous or complex that it can't be harnessed by traditional means, has become a buzzphrase in several industries. While some sectors have successfully gathered a wealth of information from their analyses, healthcare seems to be just getting started. Unlike Alice's Adventures in Wonderland, big data is not a dream that everyone will wake from. It's a powerful revolution.

As the mother of two young boys, the author used to think it was her duty to subscribe to a free e-mail service from the US Food and Drug Administration about recalls and safety alerts. \"A faulty medical device can pose the full spectrum of dangers, from not likely to have reasonable adverse health consequences to, on the other end, being capable of causing a serious injury, even death,\" says Nadia Ayoubzadeh, director of Clinical Engineering Services at Allina Health in Minneapolis. Thankfully, accredited hospitals are required to have a system in place to monitor and act on recalls.