Civil Money Penalties: Biologics, Drugs, and Medical Devices
fda-device · Food and Drug Administration · Rule · Published 1995-07-27 · Effective 1995-08-28 · 60 FR 38612
Document
Document number
95-18325
Federal Register citation
60 FR 38612
CFR reference
21 CFR 5
Type
Rule
Action
Final rule.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
1995-07-27
Effective date
1995-08-28
HHS docket
Docket No. 91N-0447
Abstract
The Food and Drug Administration (FDA) is issuing final regulations to establish hearing procedures for use when FDA proposes the imposition of administrative civil money penalties. This rule implements the civil money penalty provisions of several statutes: the National Childhood Vaccine Injury Act of 1986 (NCVIA), the Prescription Drug Marketing Act of 1988 (PDMA), the Safe Medical Devices Act of 1990 (SMDA), the Generic Drug Enforcement Act of 1992 (GDEA), and the Mammography Quality Standards Act of 1992 (MQSA).