Case Study 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 program, products are automatically classified as Class...
Case Study “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 with HIV in the countries served by the program are...
Case Study 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 equivalent, to a legally marketed device that is not...
Case Study 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. According to the FDA, NEST “[leverages] real-world...
Asia 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 be tempting, it is important to note that...
Case Study 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 E.U. and some of which are not. The two drugs had...
