CARDIAC SURGERY PRESSURE ULCER PREVENTION

| May 19, 2015

CARDIAC SURGERY PRESSURE ULCER PREVENTION

Required text book: BIODESIGN – The Process of Innovating Medical Technologies
Describe the regulatory pathway you would take your hypothetical innovation thru on its way to the market. If a device, describe its class (see Table 4.2.1), the FDA center (see p. 275), the division (see Table 4.2.2) and pathway (see Table 4.2.3). Go to the FDA medical devices databases (http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Databases/default.htm) and click on PRODUCT CLASSIFICATION and find the device closest to your innovation and provide a detailed description of the classification.

If your innovation falls under one of the other FDA centers (food, drug, cosmetic) – please answer the DQ to the extent it is applicable (foods and devices are different… but you can still answer the question of which regulatory pathway you would take). For example, for devices you would need an IDE to file a PMA; for drugs you would need an IND to file an NDA.If your innovation falls under one of the other FDA centers (food, drug, cosmetic) – please answer the DQ to the extent it is applicable (foods and devices are different… but you can still answer the question of which regulatory pathway you would take). For example, for devices you would need an IDE to file a PMA; for drugs you would need an IND to file an NDA.

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