Description
The Center for Devices and Radiological Health (CDRH) is charged with the responsibility for enforcing regulations created under the Radiation Control for Health and Safety Act of 1968 (Public Law 90-602) (the Act). The Act was later moved to the Federal Food, Drug, and Cosmetic Act (FD&C Act) with the passage of the Safe Medical Devices Act of 1990, in a new section entitled Electronic Product Radiation Control (EPRC), under Subchapter V – Part C. The regulations written under the Act are covered in 21 CFR Chapter I, Subchapter J, and the Diagnostic X-ray Performance Standards for Electronic Products. These regulations cover the manufacturing, importing, and installation of equipment that emits electronic product radiation to achieve its intended purpose or as a byproduct of meeting its intended purpose. Specific regulations under "Diagnostic x-ray systems and their major components" (21 CFR 1020.30), "Radiographic equipment" (21 CFR 1020.31), "Fluoroscopic equipment" (21 CFR 1020.32), and "Computed tomography (CT) equipment," (21 CFR 1020.33) cover aspects of the performance of each listed type of equipment and place specific requirements on the manufacturers, importers, dealers, distributors, and assemblers of the covered equipment. The term “Performance Standards” will be used in this document to refer to these regulations collectively known as the Performance Standards for Diagnostic X-ray Systems and Their Major Components. This document addresses only requirements that apply to diagnostic x-ray equipment under the EPRC provisions of the FD&C Act. This document does not address requirements that apply to such equipment under the medical device provisions of the FD&C Act.
Scope & Applicability
Product Classes
5Guidance for manufacturers of diagnostic x-ray equipment regarding radiation control regulations.; Subject of the radiation control regulations; Clarification of Radiation Control Regulations For Manufacturers of Diagnostic X-Ray Equipment; General category of equipment covered by the guidance; subject of the radiation control regulations
Equipment subject to assembly and reassembly reporting
Classification for performance standards
Not considered general-purpose radiographic systems
Classified as other than general purpose
Stakeholders
4Entity 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
Independent contractor performing assemblies for distributors
Recipient of the report of assembly copy
Entity responsible for submitting NDINs
Regulatory Context
Attributes
5Label declaring that products meet the performance regulations.
Date the unit is turned over to the facility as ready for use on patients
Requirement for components to function together within a system.
Type of compatibility defined by manufacturers of certified components.
Technical parameter for classifying x-ray systems
Identified Hazards
Hazards
2Event resulting in injurious or potentially injurious exposure to electronic product radiation.
Issues to be documented in the Comments section of the form
Related CFR Sections (9)
- 21CFR1020.30§ 1020.30 Diagnostic x-ray systems and their major components.
(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 →
- 21CFR1020.32§ 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 →
- 21CFR1020.33§ 1020.33 Computed tomography (CT) equipment.
(a) Applicability.Read full regulation →
- 21CFR1010.2§ 1010.2 Certification.
(a) Every manufacturer of an electronic product for which an applicable standard is in effect under this subchapter shall furnish to the dealer or distributor, at the time of delivery of such product, the certification that such product conforms to all applicable standards under this subchapter.Read full regulation →
- 21CFR1000.3§ 1000.3 Definitions.
As used in this subchapter J:Read full regulation →
- 21CFR1002.20§ 1002.20 Reporting of accidental radiation occurrences.
(a) Manufacturers of electronic products shall, where reasonable grounds for suspecting that such an incident has occurred, report to the Director, Center for Devices and Radiological Health, all accidental radiation occurrences reported to or otherwise known to the manufacturer and arising from theRead full regulation →
- 21CFR1010.4§ 1010.4 Variances.
(a) Criteria for variances.Read full regulation →
- 21CFR1002.40§ 1002.40 Records to be obtained by dealers and distributors.
(a) Dealers and distributors of electronic products for which there are performance standards and for which the retail price is $50 or more shall obtain such information as is necessary to identify and locate first purchasers if the product is subject to this section by virtue of table 1 of § 1002.1Read full regulation →
See Also (8)
- Clarification of Radiation Control Regulations For Manufacturers of Diagnostic X-Ray Equipment: Guidance for Industry and Food and Drug Administration Staff (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)
- Medical X-Ray Imaging Devices Conformance with IEC Standards: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Policy Clarification for Certain Fluoroscopic Equipment Requirements: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Pediatric Information for X-ray Imaging Device Premarket Notifications: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Radiation Safety Considerations for X-Ray Equipment Designed for Hand-Held Use (Status: Final)
- Information Disclosure by Manufacturers to Assemblers for Diagnostic X-ray Systems - Guidance for Industry and FDA Staff (Status: Final)