Health and Human Services Department Docket FDA-2013-N-0134 Proposed Rule

2019-05803: Mammography Quality Standards Act

Comment Period Closed

Public comment closed .

Get alerted when the next rule lands

New rules open for comment on their own schedule. Pick how you want to hear about them — we email you when one appears.

Alert me on new Health and Human Services Department rules or alert me on a subject

Publishing to members? Embed a live rule tracker on your own site — the proposed rules in your area and the comment deadlines closing on them, updating themselves. Free, one line of HTML.

Create a free account & build one →

Summary

The Food and Drug Administration (FDA or Agency) is proposing 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 proposing updates to modernize the regulations by incorporating current science and mammography best practices. These updates would 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.

The agency’s own summary, as published.

What this changes

Amends 1 part of the Code of Federal Regulations — the standing rules this notice rewrites.

Don't miss the comment window

One Click Politics alerts you on every deadline, hearing, and rule change.

See all rules with comments due soon →