The FDA’s Center for Devices and Radiological Health has recently released a list of all medical device guidance documents it plans to release in 2015. The list, also known as the “Guidance Agenda,” outlines the federal laws and regulations that are planned to be enforced and published by FDA this year. The list is prioritized and divided into two lists, an “A-List” and a “B-List,” with the “A-List” taking precedence.
The list is comprised of 28 device guidance documents including software and diagnostics. Top priority documents are related to regulating lab-developed tests (LDTs) and speeding up device submissions.