Dec 12 - 8:50
De Novo classification, also known as Evaluation of Automatic Class III Designation, is a risk-based classification process of novel devices for which there are no legally marketed predicate devices. Under this...
Dec 3 - 8:49
“Since the President’s Emergency Plan for AIDS Relief (PEPFAR) was launched 15 years ago to battle the global HIV/AIDS epidemic, more than 17 million lives have been saved and currently over 14 million people living...
Nov 26 - 9:27
Established in 1976, a 510(k) is a “premarket submission made to FDA [by medical device manufacturers] to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially...
Sep 10 - 7:54
The National Evaluation System for health Technology (NEST) enhances the medical device postmarket surveillance system by better producing evidence for medical device assessment and regulatory decision-making....
Aug 27 - 12:46
As the demand for quality healthcare in East Asian countries skyrockets, so does the potential for astronomical growth for the pharmaceutical and medical device industries. While jumping into markets in that region can...
Aug 27 - 12:42
Introduction A subsidiary of a Fortune 100 company intended to introduce two pharmaceutical products used to catalyze healthy blood clotting after surgery to 18 countries across Europe, some of which are members of the...
