Can masks prevent the spread of Corona Virus? What the CDC and FDA are saying.

New medical devices and novel uses for them should be celebrated as our world moves to continuously innovate. The FDA has been a driving force in the medical device industry’s move to innovate faster and further. One of the ways in which novel devices are brought to market is called the De Novo submission. Medical devices are generally required to go through pre-approvals prior to being marketed and sold in the U.S. Most devices go through what is called the Premarket Notific

The FDA can be a thorn in the side of many medical device companies. The regulations could make your head spin. However, the FDA has only gone on to ban one medical device in it’s history - well now, two. The ban of a product would seem to be appropriate for devices that are extremely harmful to consumers, but the FDA has banned an unlikely candidate - powdered gloves. On December 19th, the FDA published its final rule on the ban of powdered gloves. The medical device is said