As summer draws to a close, millions of Americans will likely be packing their sunscreens away for next summer, but at least one consumer advocacy group wants you to...
The U.S. Food and Drug Administration (FDA) has been very busy lately. The agency recently sent 14 warning letters to international medical device companies citing violations. The warnings, sent...
The story of power morcellators is one of utter failure on the part of the FDA. Because the agency doesn’t require doctors to report defective devices, the dangers of...
The FDA’s Center for Devices and Radiological Health (CDRH) has been incredibly busy lately. Earlier this week, the CDRH announced the completion of a project to analyze past medical...
What does a device manufacturer do when it wants to make changes to its products? Before now, that was unclear; but, the FDA issued a draft guidance that aims...
In the past five years alone, the number of high school kids using e-cigarettes has jumped up 900%. This astronomical increase caught the FDA’s attention and new regulations will...
With nearly one out of every five adults in the U.S. using wearable fitness tracking devices, the Food and Drug Administration (FDA) released a guidance communication stating the devices...
The FDA has an important and challenging job to do – protect consumers from dangerous products and medications without stifling advances in healthcare and medicine. After a string of...
The U.S. Food and Drug Administration (FDA) recently announced a reduction in fees for new medical device applications. The FDA hopes reducing the cost of applications will help encourage...
This past May, the U.S. Food and Drug Administration (FDA) issued a draft guidance regarding 3D printed medical devices and asked for comments from the medical and 3D printing...