Description
This document supersedes: "Information Disclosure by Manufacturers to Assemblers for Diagnostic X-ray Systems” issued on April 2, 2001
Scope & Applicability
Product Classes
2Safety and technical information disclosure applies to CT equipment.
The guidance focuses on information disclosure for these systems.; The guidance covers information disclosure for these systems.
Stakeholders
2Entity responsible for installing and testing diagnostic x-ray systems.; Person engaged in assembling, replacing, or installing components into a diagnostic x-ray system.; Person or entity responsible for installing and testing x-ray components.; Person or entity responsible for installing x-ray components; Individual or firm responsible for installing and reporting x-ray equipment
Entity responsible for submitting NDINs
Regulatory Context
Attributes
1Manufacturers may recover the cost of providing instructional materials.
Identified Hazards
Hazards
3Public health risk if AIAT information is unavailable.
A safety concern that must be tested for during assembly.
Radiation emitted by electronic products that requires control
Related CFR Sections (3)
- 21CFR1020.33§ 1020.33 Computed tomography (CT) equipment.
(a) Applicability.Read full regulation →
- 21CFR1020.31§ 1020.31 Radiographic equipment.
The provisions of this section apply to equipment for radiography, except equipment for fluoroscopic imaging or for recording images from the fluoroscopic image receptor, or computed tomography x-ray systems manufactured on or after November 29, 1984.Read full regulation →
- 21CFR1020.30§ 1020.30 Diagnostic x-ray systems and their major components.
(a) Applicability.Read full regulation →
See Also (8)
- Clarification of Radiation Control Regulations for Diagnostic X-Ray Equipment (Part 2) (Status: Final)
- Manufacturers/Assemblers of Diagnostic X-ray Systems: Enforcement Policy for Positive-Beam Limitation (PBL) Requirements in 21 CFR 1020.31(g) : (Status: Final)
- Radiation Safety Considerations for X-Ray Equipment Designed for Hand-Held Use (Status: Final)
- Pediatric Information for X-ray Imaging Device Premarket Notifications: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Medical X-Ray Imaging Devices Conformance with IEC Standards: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Guidance for Industry and Food and Drug Administration Staff - Assembler's Guide to Diagnostic X-Ray Equipment (Status: Final)
- Performance Standard for Diagnostic X-Ray Systems and Their Major Components (21CFR 1020.30, 1020.31, 1020.32, 1020.33); Small Entity Compliance Guide (Status: Final)
- Clarification of Radiation Control Regulations For Manufacturers of Diagnostic X-Ray Equipment: Guidance for Industry and Food and Drug Administration Staff (Status: Final)