FDA Combination Products Regulations Whitepaper

Here at Medgadget, we frequently report on the FDA approval of new devices and technologies. Over the last decade, combination products that contain medical devices embedded with pharmaceutical or biologic components have become more and more common. The FDA has struggled to keep up with reality with its regulations regarding these products, but over the last year regulations for Good Manufacturing Compliance (GMP) for combination products were introduced. If you are interested in current regulations or want to see how the process for getting a product approved works, Microtests, a company that performs medical device and pharmaceutical testing amongst other things, offers a whitepaper for download that reviews all the steps (free download, but registration is required). It offers an interesting look into all that happens before the world gets to know about the existence of a new product.
Link: Combination Products 2.0: Applying the New FDA Regulations…