If the SFDM receptor is part of a mammography unit that is used solely for interventional procedures, the unit and the receptor are excluded from all MQSA requirements.
If the SFDM receptor is part of a mammography unit that is used for mammography, either screening and/or diagnostic, then the unit and the SFDM receptor must meet the following MQSA requirements:
- The unit must be accredited and certified (section 354(d)-(e) of the MQSA). The SFDM receptor does NOT have to undergo a separate accreditation or certification.
- The SFDM receptor manufacturer must have obtained marketing clearance from FDA’s Office of Device Evaluation for diagnostic mammography use of the SFDM receptor (21 CFR part 807, subpart E, 21 CFR 900.12(b)(1), (2)). This is usually stated in the labeling information in the receptor manual. If the facility is unsure whether the particular model of SFDM receptor it plans to use has received such clearance, it can contact the manufacturer.
- Personnel must meet all applicable MQSA requirements (21 CFR 900.12(a)). For SFDM this means that, in addition to the basic requirements, personnel who only had training in film-screen mammography would need to have 8 hours of training in digital mammography (either FFDM or SFDM) prior to independently using the SFDM receptor clinically (21 CFR 900.12(a)(1)(ii)(C), (a)(2)(iii)(E), (a)(3)(iii)(C)). Personnel who already had 8 hours of training in FFDM would NOT have to obtain additional training. Note: Personnel who use SFDM for diagnostic purposes prior to January 1, 2006 will be considered to have met the 8 hour requirement. Such personnel can attest to or document this experience.
- Facilities must have the receptor pass a mammography equipment evaluation prior to initial use (21 CFR 900.12(e)(10)) and must follow the SFDM manufacturer's quality control manual with respect to periodic testing (21 CFR 900.12(e)(6)). The receptor must also be checked as part of the annual physics survey (21 CFR 900.12(e)(6), (9)).