The FDA has approved the American College of Radiology (ACR) to accredit the Agfa full field digital mammography (FFDM) system beginning Sept. 14, 2012.
The ACR will contact facilities already using the Agfa FFDM system under an FDA-approved extended MQSA certificate to advise them of this change and how to proceed with accreditation. Such facilities need not take any action toward accreditation until they are contacted by the ACR, and are permitted to operate during the transition period.
Beginning Sept. 14, 2012, the FDA will no longer accept applications to extend existing MQSA certificates to include the use of Agfa FFDM systems. As of that date, facilities should contact the ACR for information on how to begin the accreditation process.
The following systems must be accredited:
- Agfa Computed Radiography
- Carestream DirectView (computed radiography)
- Fischer Senoscan
- Fuji FCRm, Aspire CR (computed radiography)
- Fuji Aspire HD (FDR)
- General Electric Senographe 2000D, DS, Essential, Senographe Care
- Konica Minolta Xpress (computed radiography)
- Lorad Selenia, Selenia S, Selenia Dimensions, Selenia Encore
- Philips (Sectra) MicroDose Mammography L30
- Planmed Nuance and Nuance Excel
- Siemens Mammomat Novation DR, Mammomat Novation S, Mammomat Inspiration, Mammomat Inspiration Pure
Applicants with other FFDM systems must continue to apply to and be approved by the FDA for extension of their certificates to include the use of an FFDM unit in order to operate those systems legally.