Mammography Facility Inspections - Part VII: Center Responsibilities

PART VII - CENTER RESPONSIBILITIES

1. CDRH / OCER / DMQRP

   1. Provide calibrated test equipment for use by all FDA and State inspectors (calibration of x-ray monitors by the Radiation Metrology Branch, DIAM/OSEL/CDRH) (Note: the MQSA inspection procedures no longer include routine radiation measurements. Radiation measurements, such as exposure measurements for dose, beam quality, and reproducibility, would only be done as needed to investigate possible problems.
   2. Review regulatory action recommendations and provide assistance and guidance in the preparation of compliance cases, including the Directed Plan of Correction. For Civil Money Penalties, suspension, revocation, and injunctions under MQSA, DMQRP and the CDRH Office of Compliance will work closely together regarding these actions.
   3. Maintain/develop computer software for direct access to MPRIS Web by inspectors, auditors, and RRHR's.
   4. Recommend specific sites for special inspections when requested.
   5. Develop and revise facility inspection procedures.
   6. Provide training courses for MQSA inspectors and administer MQSA inspector certification and quality assurance programs.
   7. Develop regulatory guidance for inspectors and FDA field offices.

2. Program Review

   On a routine basis, but not less often than annually, this program will be reviewed. This review will be the results of this program and any needed improvements to increase program effectiveness. Program changes and recommendations should be submitted to the Chief, Diagnostic Devices Branch, DMQRP for consideration.