What if one ideal global Regulatory system exists? What Parts of the FDA will it still has and what other could be changed?.
All different regulatory systems have a lot in common which always looks for safety and efficacy of new devices. The most important part in my opinion is the Cost. It affects a lot of the companies projects, for example the Cost for obtaining the CE mark is much less than FDA, which is affected by FDA Requiring a full clinical trials, where CE is obtained through a clinical evaluation of published data for existing equivalent devices.
What else can be changed ?
The Global Harmonization Task Force (GHTF) which is currently the International Medical Device Regulators Forum (IMDRF), has a goal of bringing together medical device regulatory systems around the world by enhancing patient safety and increasing access to safe, effective and clinically beneficial medical technologies. The GHTF was comprised of five Founding Members: European Union, United States, Canada, Australia and Japan. The FDA would still abide by the phases used in clinical trials used for drugs but I believe they would change their risk based device classification system. With a few exceptions, countries such as Switzerland, Turkey, and Japan follow these regulations. The FDA stated that they believe their regulation system is "more mature". In my personal opinion, if the same drugs and devices are used worldwide, why are there so many different regulations?
References:
Institute of Medicine (US) Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process. “The Global Framework for Regulation of Medical Devices.” Public Health Effectiveness of the FDA 510(k) Clearance Process: Balancing Patient Safety and Innovation: Workshop Report., U.S. National Library of Medicine, 1 Jan. 1970, www.ncbi.nlm.nih.gov/books/NBK209785/.
The Global Harmonization Task Force (GHTF) which is currently the International Medical Device Regulators Forum (IMDRF), has a goal of bringing together medical device regulatory systems around the world by enhancing patient safety and increasing access to safe, effective and clinically beneficial medical technologies. The GHTF was comprised of five Founding Members: European Union, United States, Canada, Australia and Japan. The FDA would still abide by the phases used in clinical trials used for drugs but I believe they would change their risk based device classification system. With a few exceptions, countries such as Switzerland, Turkey, and Japan follow these regulations. The FDA stated that they believe their regulation system is "more mature". In my personal opinion, if the same drugs and devices are used worldwide, why are there so many different regulations?
References:
Institute of Medicine (US) Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process. “The Global Framework for Regulation of Medical Devices.” Public Health Effectiveness of the FDA 510(k) Clearance Process: Balancing Patient Safety and Innovation: Workshop Report., U.S. National Library of Medicine, 1 Jan. 1970, www.ncbi.nlm.nih.gov/books/NBK209785/.
I agree with you Meagan. I believe that the clinical trials phases should stay as they are because they help determine some really important information about the drugs or devices. Those trials help determine the long terms effects, the product efficacy, the risks of the product and so much more. The trials are important even though they are very expensive. The FDA saying that they believe their system is "more mature" is pretty arrogant. There has been products that have been approved by the FDA, but later on caused some serious, life-threatening health problems for people, so their system is not perfect. I believe that they should join GHTF, and align their regulatory systems with theirs. This way they devices and drugs that are approved are looked at by many people with different backgrounds, and not just one organization where everyone has similar experiences and views.
