In this discussion, we can refer back to our last discussion regarding the challenges in the medical devices industry, in which most replies stated that FDA approval and regulations are the most challenging step in developing a new medical device or medical drug. I wouldn’t agree with saying that FDA is too tough and strict. Going over their statement which shows and researching more about the regulation and approval steps can tell that it is not an easy and fast process. As it is linked to human life and public health safety, one should expect the highest level of ensuring security, safety, and effectiveness of a new treatment or new medical device which would involve a long process of clinical trials and lab tests.

On their website, FDA clarified their drug development designations system as there is a “Fast Track” which is related to treating serious conditions (life-threatening) that need a quick and early drug approval. The next one was the “Breakthrough Therapy” designation that is responsible for reviewing drugs that cure serious conditions which in particular may have a worthy advancement over a ready-to-use treatment (which is clinically significant). The third designation is the “Priority Review”, that is will direct the all resources of the drug to the evaluation step. This would work in case the drug has a high possibility that if it was approved quickly it will significantly improve diagnosing or preventing serious conditions when unlike normally available solutions and applications. However, the quality of testing and approving a drug or medical device would not be altered in any case. Speeding FDA approval process would certainly solve the problem of the new pharmaceuticals development delays and the decline in the past year.