United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2023_register executive 2023-03-10 article Part II Rules and Regulations D09002ee1c79dfaef D09002ee1c79dfd47 United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency The Food and Drug Administration (FDA, Agency, or we) is issuing a final rule to update the mammography regulations that were issued under the Mammography Quality Standards Act of 1992 (MQSA) and the Federal Food, Drug, and Cosmetic Act (FD&C Act). We are issuing updates to modernize the regulations by incorporating current science and mammography best practices. These updates are intended to improve the delivery of mammography services by strengthening the communication of healthcare information; allowing for more informed decision making by patients and providers (by requiring facilities to provide them with additional health information); helping to ensure the availability of qualified mammography personnel; bolstering the medical outcomes audit to provide feedback to improve mammography interpretations; modernizing technological aspects of the standards; and adding additional tools to deal with noncompliant facilities. 88 FR 15126 https://www.govinfo.gov/app/details/FR-2023-03-10/2023-04550 2023-04550 fr10mr23-17 RIN 0910-AH04 4164-01-P Docket No. FDA-2013-N-0134 https://www.govinfo.gov/app/details/FR-2023-03-10/2023-04550 https://www.govinfo.gov/content/pkg/FR-2023-03-10/html/2023-04550.htm https://www.govinfo.gov/content/pkg/FR-2023-03-10/pdf/2023-04550.pdf Electronic Products Health Facilities Medical Devices Radiation Protection Reporting and Recordkeeping Requirements X-Rays 46 p. 15126 15171 88 FR 15126 Title 21 Part 900 21 CFR Part 900 RIN 0910-AH04 Mammography Quality Standards Act; Federal Register Vol. 88, Issue RULE 2023-04550 II DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2024-09-10 Docket No. FDA-2013-N-0134 4164-01-P 2023-04550 Final rule.

The Food and Drug Administration (FDA, Agency, or we) is issuing a final rule to update the mammography regulations that were issued under the Mammography Quality Standards Act of 1992 (MQSA) and the Federal Food, Drug, and Cosmetic Act (FD&C Act). We are issuing updates to modernize the regulations by incorporating current science and mammography best practices. These updates are intended to improve the delivery of mammography services by strengthening the communication of healthcare information; allowing for more informed decision making by patients and providers (by requiring facilities to provide them with additional health information); helping to ensure the availability of qualified mammography personnel; bolstering the medical outcomes audit to provide feedback to improve mammography interpretations; modernizing technological aspects of the standards; and adding additional tools to deal with noncompliant facilities.

This rule is effective on September 10, 2024. Preetham Sudhaker, Division of Mammography Quality Standards (DMQS), Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Silver Spring, MD 20993, 301-796-5911. 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