Description
The purpose of this Compliance Policy Guide is to indicate when the Agency will recommend civil penalties.
Scope & Applicability
Product Classes
2Specific guidance for assemblers of these systems is in CPG 7133.12
Broad category including laser products regulated by CDRH.
Stakeholders
3Installers of diagnostic X-ray systems; Entities installing X-ray equipment.
persons affected by prior notice rules
Responsible for declaring acceptable market names on labels.
Identified Hazards
Hazards
1Threshold for requiring an onsite audit of a supplier
Related CFR Sections (1)
- 21CFR17.2§ 17.2 Maximum penalty amounts.
The maximum civil money penalties associated with the statutory provisions authorizing civil money penalties under the Federal Food, Drug, and Cosmetic Act or the Public Health Service Act can be found at 45 CFR part 102 . The table of these maximum civil money penalties can be found at 45 CFR 102.3Read full regulation →