What would be the advantage of sending my credentials to the FDA headquarters for review?
We see two possible benefits for you. First, if you are in doubt about whether you meet any of the initial requirements, this is an opportunity to get an answer from FDA. Second, after the review, a letter signed by the Director of FDA's Division of Mammography Quality Standards, will identify the initial requirements that you have met. This letter can be given to the facilities you serve in place of the documents related to those initial requirements that you presently provide to them for evaluation and credentialing purposes. This will reduce the volume of material that has to be given to the facility. Note: You will still need to supply all facilities where you provide mammography services a copy of your Board certification or a current State approval or State license. Please be aware that if your State approval or State license expires after a certain period, you must provide your facilities with a new copy of the documentation after each renewal.