Mammography Facility Inspections - Part VI: References, Attachments and Program Contacts

PART VI - REFERENCES, ATTACHMENTS AND PROGRAM CONTACTS

1. References

   1. United States Code, Title 42, Mammography Quality Standards Act of 1992 (Public Law 102-539)
   2. United States Code, Title 42, Mammography Quality Standards Reauthorization Acts of 1998 and 2004, (Public Laws 105-248 and 108-365)
   3. Code of Federal Regulations, Title 21, Part 900
   4. Federal Register, Final Quality Standards for Mammography (62 F.R. 55852, Oct. 28, 1997)
   5. MQSA Inspection Procedures which can be found at http://www.fda.gov/Radiation-EmittingProducts/MammographyQualityStandardsActandProgram/FacilityCertificationandInspection/ucm114146.htm
   6. Compliance Guidance - The Mammography Quality Standards Act Final Regulations Documents. These can found at http://www.fda.gov/Radiation-EmittingProducts/MammographyQualityStandardsActandProgram/Guidance/default.htm. New documents pertaining to MQSA are posted on this site in draft and final. Once issued in final, they are eventually incorporated into the Policy Guidance Help System, which can be found at http://www.fda.gov/Radiation-EmittingProducts/MammographyQualityStandardsActandProgram/Guidance/PolicyGuidanceHelpSystem/default.htm
   7. Investigations Operations Manual, FDA
   8. Regulatory Procedures Manual, FDA
   9. Federal Register, Interim Quality Standards for Mammography (58 F.R. 67558, Dec. 21, 1993)
   10. United States Code, Title 21, Federal Food, Drug, and Cosmetic Act, As Amended
   11. Compliance Program 7386.003, Field Compliance Testing of Diagnostic (Medical) X-ray Equipment (http://www.fda.gov/downloads/ICECI/ComplianceManuals/ComplianceProgramManual/ucm125442.pdf)
   12. MQSA Auditor's Guide (http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074895.htm)

2. Attachments

   List of CDRH personnel to contact on inspection and compliance procedures, case management, inspection audits, and workplans

   1. List of CDRH personnel (inspection, compliance, audits, and workplans)
   2. List of CDRH personnel to contact on inspection computer support and testing equipment
   3. List of MQSA Auditors
   4. Form FDA 2766 Claim for Damage to an Electronic Product
   5. Observation Statements for MQSA Inspections
   6. Guidance for Evaluating a Facility Response
   7. Guidance for an Additional Mammography Review (AMR)
   8. Flowchart - Follow-Up for MQSA Inspections
   9. Warning Letter for inspections with repeat level 1, level 1 and or repeat level 2 inspection observations
   10. Adequate Response Letter to Facility
   11. Example of MQSA Facility Inspection Report
   12. Important Information about Your MQSA Inspection (given to facility at the close of the inspection)
   13. Sample MQSA Inspection Confirmation (5 days prior to inspection)

3. Program Contacts

   1. CDRH Contact - Questions concerning this compliance program should be directed to Michael P. Divine, Inspection and Compliance Branch, Division of Mammography Quality and Radiation Programs, OCER, michael.divine@fda.hhs.gov. Secondary contact may be made with the individuals listed on Attachments A through C.
   2. ORA Contact - The ORA Headquarters contact for this compliance program and state contract issues is Preetham Sudhaker, Division of Federal-State Relations ORO (HFC-152), preetham.sudhaker@fda.hhs.gov.