This week’s lecture got me thinking on how the FDA regulates a product that is both a medical device and a drug. There are clear and separate regulations for medical devices and drugs individually but what happens when you have a product that falls in between both sectors? For example, drug delivery systems may be a device that slowly releases a specific device at a controlled rate – how would the FDA regulate such a product? Another example would be if an implant was surface treated with an antibiotic, does this complicate the regulation process since this medical device has a drug surface treatment as well?