It seemed to me that most of the effort for the MasterLab was to teach advocates like me how to effect change on the hill in Washington. Whether it be in Congress or the FDA. They had a great presentation from Stayce Beck of the FDA explaining the approval process for medical devices like our pumps, cgms, and blood glucose meters. She was conveying a great deal of info, and using acronyms and terms I didn’t understand. As I sat there, I thought I couldn’t be the only person that was a little lost, so I’ve been trying to educate myself on the FDA approval process. Below is a short breakdown in layman’s terms of what I’ve learned. If I’m wrong about anything, please leave a comment. I’m certainly no expert, but wanted to share what I’ve learned.
Congress passes LAWS, but executive agencies like the FDA, which are created by congress, issue RULES. Both laws and rules seem to have the same legal effect. Congress has little to do with RULE making, but they do have the ability to overturn, or stop a rule from being created, as does the President.
Both the FDA and YOU, the constituent have the ability to create a proposed rule. The process of creating a RULE, is that a “draft of proposed rule” is created and sometimes submitted to the president for review. Then it’s created in the Federal Register, an electronic database and webpage, where the details of the rule are explained. This also triggers the notification to the public of the proposed rule, and the opportunity for the public to comment, which usually lasts 60 days (but that time frame isn’t set in stone). Once created in the federal register, it’s known as a “docket”. Stayce explained that this is a very important part of the rule making process. When we comment, it makes a difference. Especially when we ALL COMMENT. Then after the comment period passes, the FDA decides whether to submit a new proposed rule with changes, or go ahead and create a “draft final rule”. Next, it’s sent to the president for review, and then to congress. If they don’t disapprove the draft final rule, it becomes a final rule at which point it is entered into the Federal Register and the Code of Federal Regulations.
These 2 documents really helped me understand this process. For more details about this process, first read this Rule Making Process PDF, then read this Federal Register Tuturial. Finally, to try to keep up on what the FDA is doing, go to their homepage where you can find links to RSS feeds, how to connect with them on social media, and sign up for their email newsletters. The link is http://www.fda.gov/.