other · Food and Drug Administration · Rule · Published 2023-03-10 · Effective 2024-09-10 · 88 FR 15126
Document
Document number
2023-04550
Federal Register citation
88 FR 15126
CFR reference
21 CFR 900
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2023-03-10
Effective date
2024-09-10
HHS docket
Docket No. FDA-2013-N-0134
Abstract
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.