Does a facility have to have its FFDM unit accredited?
If your State accreditation body or ACR has received FDA approval to accredit your specific model FFDM unit, then you must have your unit accredited by one of those bodies to qualify for certification. 21 C.F.R. 900.11(a). If neither your State accreditation body nor ACR has received FDA approval to accredit your specific model FFDM unit, then you need to ask FDA to extend your current certification to cover your FFDM unit before you can use it clinically.