We have been using our FFDM unit under FDA’s certification extension policy. Now that there is an accreditation body for our model FFDM unit, what do we need to do to have the unit accredited? We were keeping our old film-screen-unit just to be eligible for the certification extension policy. Do we still need to keep this film-screen unit?
Your facility must follow the accreditation body’s procedures for accreditation of your model FFDM unit. 21 C.F.R. 900.11. The facility may continue to operate its FFDM unit under FDA’s certification extension policy while it applies for and proceeds through the accreditation process. Once you have started the accreditation process, you no longer are required to keep your film-screen unit.