The Food and Drug Administration (FDA) has announced the release of a draft guidance entitled "The Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System 13." The document is to provide guidance to mammography facilities and their personnel, regarding the FDA's current thinking on the final regulations implementing the Mammography Quality Standards Act of 1992 MQSA). The guidance is not final or currently in effect.

The FDA says people may comment on the guidance at any time but in order for the agency to consider comments before it works on the final version of the guidance, comments should be submitted in writing or by electronic means by January 7, 2010.

The draft guidance updates the Policy Guidance Help System and addresses or contains the following: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. Labeling of mammographic images;
7. Mammographic modality and its impact on personnel experience requirements;
8. Clarification of the personnel 6-month exemption period;
9. Information on calibrating the air kerma measuring instrument;
10. Medical physicist involvement as it applies to cassette replacement;
11. Full Field Digital Mammography (FFDM) and use of single-use cushion pads;
12. Quality control testing of computer controlled compression devices;
13. Mammography equipment evaluations of laser printers;
14. Quality control testing of monitors and laser printers;
15. Mammography equipment evaluations of new FFDM units; and
16. Mammography equipment evaluations of off-site laser printers and monitors.

The FDA's guidance documents do not establish legally enforceable responsibilities but rather are recommendations that reflect the agency's current thinking unless specific regulatory or statutory requirements are cited. The FDA requests that any written comments concerning the draft guidance be submitted to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Electronic comments can be submitted to http://www.regulations.gov. Comments should be identified with the docket number [Docket No. FDA-2009-D-0448]

More information on the draft guidance can be found at: http://edocket.access.gpo.gov/2009/pdf/E9-24435.pdf

The draft guidance may be obtained from regulations.gov.

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