Activity

  • jjp93 replied to the topic FDA rules too strict? in the forum Regulatory Basics for Medical Devices 6 years, 7 months ago

    I believe that FDA is not slowing down the process of the product with all the rules and regulations that they follow. They have strict guidelines that are supposed to help make sure the product that is being made is not harmful to anyone. By them going through each step, each documentation, and making sure all the methods and procedures are followed, it makes the product less likely to have issues. Even if the product has issues in the future, everything can be traced back with the documentation and methods that were used because of how strict the FDA is. I also believe that FDA could become stricter because outside the USA, there are different drugs that are banned in those countries but not in the US. For instance, the usage of opioid painkillers is much more regulated in Japan, Europe, Germany and other countries in the UK. There are still people in those countries breaking bones and having surgery, but they are less dependent on opioid painkillers while in the US, there are more people depending on the drug. If FDA were stricter about how these drugs were used, there would be less people dependent on drugs just like how it is handled in Europe. FDA’s strictness can slow down the process but that means taking the time to work on a drug and make sure it doesn’t have any flaws. These drugs and medical devices are going into people and could be very risky, so these products must be safe for people to use. Without FDA regulations, there would be more people getting sick and injured. I believe the strictness and delays are beneficial in the long run.