FDA initiative develops informational video to prep for inspections
As part of the FDA’s Enhancing Quality Using the Inspection Program (EQUIP) Initiative, the Division of Mammography Quality Standards (DMQS) developed another tool to enhance facility understanding of what inspectors will be looking for and not looking for with the new EQUIP questions.
Director of DMQS Helen Barr, MD, and her colleagues created an informational video featuring a mock inspection scenario that will assist inspectors in preparing for questions from facilities that might arise during close out discussions.
The FDA established the EQUIP Initiative in September 2016 to address MQSA requirements for corrective action in the face of substandard images and the role of the lead interpreting physician in the quality assurance process.
Click here to view the informational video.