Activity

  • I do not think that the medical device community as a whole is moving towards a globalization of regulatory procedures because as we have learned in lecture, the approach to regulation regarding drugs and medical devices has been a reactive process. The two examples being the Biologics Act of 1902 after a tetanus outbreak from diphtheria antitoxin, and the Food, Drug & Cosmetic Act of 1938 after people died from drinking an elixir containing antifreeze. As time goes on countries may begin to copy each other’s regulatory practices, changing their regulations as they learn from another country’s mistakes, but I don’t think it will get to the point where there is one governing body for globalized regulatory procedures. In my opinion I believe having separate regulations for each country is beneficial because there is this pseudo-competition for each country to be the “top dog,” and by reacting to another country’s increase in regulation allows for the development of regulatory processes that are enough to maintain safety and efficacy without slowing down the roll out of a device due to overkill regulation.