Abstract:distribution, display, etc. QUESTION: When a for-profit company files for approval from the Federal Drug Administration, either for a new drug or medical device, the company must provide copies of all articles and other literature, along with the filing. Now, in Europe, there is a Medical Device directive, MEDDEV.2.7.1 Rev.3-Guidelines on Medical Devices, that requires all manufacturers who want to sell product in European Union countries to provide a clinical evaluation of their product. Part of the evaluatio… Show more
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