Today FDA released the DRAFT FDA guidance "Unique Device Identification System: Form and Content of the Unique Device Identifier." While FDA's final rule was passed September 24, 2014, this is their first guidance on the subject.
0 Comments
The U.S. House of Representative passed the 21st Century Cures Act in July of 2015. It was then sent over to the U.S. Senate and has since been referred to the Senate Committee on Health, Education, Labor, and Pensions.
Within this bill there are references to 22 (from my count) guidance documents FDA is required to author if the bill is passed. Below is the list guidance documents I identified that the FDA will be required to create or update and complete once the 21st Century Cures Act is signed into law. I have also included the House of Representatives projected timelines for completion, which may change in the Senate. Because the Senate has yet to take up and pass this legislation, allowing the President to sign it into law, some of the projected completion dates for certain guidance’s are unlikely to be met. I will update this list with any changes based on a Senate passed bill. Guidance List:
|
John Van Hoven, MS
I started this blog to document my thoughts on working in the medical product regulatory field, in particular my experiences working with the FDA. I hope you find it somewhat helpful. Archives
August 2016
Categories |