The FDA has approved the American College of Radiology (ACR) to accredit the Planmed Nuance and Nuance Excel full field digital mammography (FFDM) systems beginning Dec. 27.
With ACR accreditation available nationwide, the FDA will end its Certification Extension Program for these units as of Dec. 27. Facilities in Arkansas, Iowa or Texas that want to install and use these units must either apply to ACR for accreditation or wait for their respective state accreditation body to become approved by the FDA to accredit these units.
The ACR will begin contacting facilities which already use Planmed systems under an FDA-approved extended Mammography Quality Standards Act (MQSA) certificate to advise them of this change and how to proceed with accreditation. These facilities don’t need to take any action towards accreditation until they are contacted by the ACR, and will be allowed to operate during the transition period.
Also starting Dec. 27, the FDA will no longer accept applications to extend existing MQSA certificates to include the use of the Planmed systems, and facilities should contact the ACR for information on how to begin the accreditation process.
The following systems must be accredited:
• Carestream DirectView (computed radiography)
• Fischer Senoscan
• Fuji FCRm (computed radiography)
• General Electric Senographe 2000D, DS, Essential, Senographe Care
• Planmed Nuance and Nuance Excel
• Lorad Selenia, Selenia S, Selenia Dimensions, Selenia Encore
• Siemens Mammomat Novation DR, Mammomat Novation S, Mammomat Inspiration, Mammomat Inspiration Pure
• Philips (Sectra) MicroDose Mammography L30
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.