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.