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GUIDANCE DOCUMENT

The Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System #13 Guidance for Industry, MQSA Inspectors and FDA Staff November 2010

Download the Final Guidance Document
Final
Docket Number:
FDA-2009-D-0448
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

This document is intended to provide guidance to mammography facilities and their personnel. It represents the Food and Drug Administration’s (FDA) current thinking on the final regulations implementing the Mammography Quality Standards Act (MQSA) (42 U.S.C. 263b). This guidance updates the Policy Guidance Help System and addresses or contains the following:

  1. Updated contact information for accreditation bodies and certification agencies;
  2. General guidance regarding Additional Mammography Reviews (AMRs);
  3. Previously approved alternative standards;
  4. Centers for Medicare and Medicaid Services (CMS) reimbursement;
  5. Mechanisms to inform physicians and patients of mammography results;
  6. Mammographic modality and its impact on personnel requirements;
  7. Clarification of the personnel 6-month exemption period;
  8. Information on calibrating the air kerma measuring instrument;
  9. Medical physicist involvement as it applies to cassette replacement;
  10. Full Field Digital Mammography (FFDM) and use of single-use cushion pads;
  11. Quality control testing of computer controlled compression devices;
  12. Mammography equipment evaluations of laser printers;
  13. Quality control testing of monitors and laser printers;
  14. Mammography equipment evaluations of new FFDM units; and
  15. Mammography equipment evaluations of off-site laser printers and monitors.

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Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2009-D-0448.

 
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