In this module I have given you basic information on the FDA and regulation of medical devices. That is good to know, just so you can function in this industry. However, if you are going to develop devices, the real thing to do is to be up on the latest news with the FDA and the regulatory atmosphere, because it will always impact your projects.

Within the last few years the thing that is all the rage in the Regulatory world is how the FDA is re-examining the 510(k) process due to some failures of the system.

For example, the Institute of Medicine issued a report awhile ago on its opinion of the 510(k) process. Can you look into this and give updates on what its about? What impact can this have on medical device development?

Post your references.