Description
U.S. Department of Health and Human ServicesFood and Drug AdministrationCenter for Devices and Radiological Health
Scope & Applicability
Product Classes
2Radiation safety considerations for unique equipment features
Radiation safety considerations for x-ray equipment designed for hand-held use.
Stakeholders
3manufacturers are responsible for ensuring that their labels conform to all applicable FDA labeling laws
Person whose actions may cause a product to be deemed adulterated
Entity responsible for submitting NDINs
Regulatory Context
Attributes
1precautions necessary to reduce operator exposure
Identified Hazards
Hazards
3identify the unique exposure hazards posed by the equipment
Radiation from the patient and nearby structures.
Radiation emanating from the diagnostic source assembly except for the useful beam
Related CFR Sections (4)
- 21CFR1020.30§ 1020.30 Diagnostic x-ray systems and their major components.
(a) Applicability.Read full regulation →
- 21CFR1020.33§ 1020.33 Computed tomography (CT) equipment.
(a) Applicability.Read full regulation →
- 21CFR1020.32§ 1020.32 Fluoroscopic equipment.
The provisions of this section apply to equipment for fluoroscopic imaging or for recording images from the fluoroscopic image receptor, except computed tomography x-ray systems manufactured on or after November 29, 1984.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 →
See Also (8)
- Clarification of Radiation Control Regulations for Diagnostic X-Ray Equipment (Part 2) (Status: Final)
- Guidance for Industry and Food and Drug Administration Staff - Assembler's Guide to Diagnostic X-Ray Equipment (Status: Final)
- Clarification of Radiation Control Regulations for Diagnostic X-Ray Equipment (Part 3) (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)
- Manufacturers/Assemblers of Diagnostic X-ray Systems: Enforcement Policy for Positive-Beam Limitation (PBL) Requirements in 21 CFR 1020.31(g) : (Status: Final)
- Information Disclosure by Manufacturers to Assemblers for Diagnostic X-ray Systems - Guidance for Industry and FDA Staff (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)