Throughout the years lawmakers and government departments such as the FDA have modified and added regulations to ensure that it tackles on all possible issues and meets their mission statement while maintaining a watchful eye on any possible failures in the system. The FDA currently is working on setting up regulations for new medical devices for example that is involved more heavily with technology such as products that transmit patient information over-the-air via internet access or bluetooth, or other devices that are becoming innovative and requires heavy testing for classification. Using the current system with these new devices and having 510 (k) and PMA to regulate it becomes difficult, this is more or less why these two documents have become greatly extensive and covering many grey areas as possible. As the previous participant on this forum mentioned, the Institute of Medicine has made conclusions on the 510 (k) clearance process and how these systems are clearing new products. The problem here lies that most products are being too similar to one another and it is becoming harder to evaluate the safety of these products because they can lie within the acceptable range but may exhibit flaws and potentially harm the general public. A new standard might need to be initiated to reflect with today’s current age of medical device development and the future as well.