Thanks wms7 for this explanation. I'm new to the project management of a medical device. The office of combination products seems makes so much sense. As proper assignment seems to be hardest question to answer for a combination device. I'm curious to know, have'nt read too many other post. Do they monitor the outcomes of the device assignments to divisions, CDHR and others? Ultimately, what are the outcomes of misguided placement? Alternatively, is following proper protocols at the department assignment what's most important?
The United States historically has been the world's largest market for pharmaceuticals. However, this lead h<1s been narrowing as managed care and generic substitution in the U.S. have slowed the growth of the drug industry by some economic measures. Access to the U.S. market demands compliance with Food and Drug Administration (FDA) requirements. Since 1962, however, there has been an international 'drug lag' between the U.S. and Europe,
where pharmaceutical companies sometimes have attained marketing approval prior to attaining it in the United
States. Until now, the US has been the world's largest market and the FDA's position as the 'gold standard' for determining a drug's safety and efficacy has gone unchallenged. However, the creation of a single market in Europe
(making it larger than the U.S. market) and the opening of the European Medicines Evaluation Agency (EMEA) in January of 1995 they had challenged the FDA's leadership, putting the agency under substantial pressure to change. The pharmaceutical industry has a responsibility to its shareholders to seek the most financially attractive market which historically has been the U.S.
In the case of a combination device, the FDA would look at the Primary Mode of Action. Once determined, the device will be assigned to one of the three agencies: CBER, CDRH, and CDER. After the device is assigned, it will follow the pathway designated for that agency. The device will be assigned to a Class (1-3) and sent for approval by the FDA based on the application pathway. The device's safety and efficacy may be called into question given its complexity and would have to be evaluated before being considered for market. This process is critical when trying to get a combination product passed because the device's complexities may be a combination as well. To evaluate this, a Regulatory Specialist must make sure this process is done smoothly with no questions from the FDA.
This week it was interesting to learn about the FDA regulations on medical devices and the different classifications Class I, II, and III. There are layers of regulatory control, and they increase from Class I to Class III. The device classification regulation defines the regulatory requirements for a general device type.
There are also different sub-branches of the FDA.
Center for Devices and Radiological Health CBER
Center for Drug Evaluation and Research | CDER.
Center for Biologics Evaluation and Research (CBER)
It was interesting to learn about the different centers and that there are completely different applications that are needed for the different centers.
@kc4310 Hey Kc you bring up some great questions, I also agree that it makes sense that there ate different centers.
