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Quality Mammography Standards

hospital-facility · Food and Drug Administration · Rule · Published 1997-10-28 · Effective 1999-04-28 · 62 FR 55852

Document

Document number
97-26351
Federal Register citation
62 FR 55852
CFR reference
21 CFR 16
Type
Rule
Action
Final rule.
Category
hospital-facility
Sub-agency
Food and Drug Administration
Publication date
1997-10-28
Effective date
1999-04-28
HHS docket
Docket No. 95N-0192

Abstract

The Food and Drug Administration (FDA) is amending its regulations governing mammography. Amendments are being made to the requirements for accreditation bodies; procedures for facility certification; and quality standards for mammography personnel, equipment and practices, including quality assurance. This action is being taken to provide increased assurance of adequate and consistent evaluation of mammography facilities on a nationwide level and compliance of the facilities with quality standards. It also carries out the intent of Congress that FDA replace the existing interim rules with more comprehensive final regulations.

Source

Authoritative
Federal Register document
Machine
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