Medical product design process review

Fast track program This program was added under the FDA Modernization Act of1997 as an extension of the accelerated drug and biologic product approval process. It was designed to facilitate development and expedite review for products that demonstrate potential or unmet medical needs in the treatment of serious or life-threatening conditions. 

Products reviewed range from toys to medical devices to cars to boats to underwater devices to containers to springs to pipes to buildings to aircraft to spacecraft and so on. The reader s product to be designed and/or fabricated can directly or indirectly be related to plastic materials, fabricating processes, and/or product design reviews in the book. 

All information supplied through a pharmaceutical company marketing department will be regarded as promotional in nature. After all, the information would not be disseminated unless it was designed to increase the consumption of the medicinal product in question. Information can only be regarded as non-promotional if its dissemination is supervised by the medical department and is clearly scientific and factual in nature. Even then it should be clearly understood that information sent out by the medical department can be subject to and considered under the Code of Practice. The concept of promotional information can be readily controlled and be acceptable to prescribers as unbiased information when it has been seen to be subject to medical department review and approval in the same way that promotional material is reviewed and approved. Indeed, one would advise that when scientific information is to be used on a promotional basis, for example a scientific article or medical report, it should be clear that the piece is being used with the support of the medical department review process. 

With new plastics and processes always becoming available, the design challenge becomes easier, even when taking today s solid-waste problem into account. Today s plastics and processes, as reviewed throughout this book, allow designers to incorporate and interrelate all the aspects of success. In products such as electronics, medical devices, transportation controls (as for aircraft, cars, and boats), and many others where user-friendly design is required, it has to be obvious to all that plastics play an important role. 

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