Description
This is aclarificationto the FDA position regarding Radiation Control Regulations for Diagnostic X-Ray Equipment.
Scope & Applicability
Product Classes
3Electronic product designed for irradiation of the human body for diagnosis; Equipment subject to radiation control regulations and assembly reporting.
Guidance 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
Certified system requiring field limitation and alignment
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
3The date the x-ray system is released to the facility for use on humans.
Manufacturer established tolerance levels for technique factors.
Includes peak tube potential, tube current, and exposure time
Related CFR Sections (4)
- 21CFR1020.30§ 1020.30 Diagnostic x-ray systems and their major components.
(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 →
- 21CFR1010.3§ 1010.3 Identification.
(a) Every manufacturer of an electronic product to which a standard under this subchapter is applicable shall set forth the information specified in paragraphs (a)(1) and (2) of this section. This information shall be provided in the form of a tag or label permanently affixed or inscribed on such prRead 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)
- Clarification of Radiation Control Regulations For Manufacturers of Diagnostic X-Ray Equipment: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- CPG Sec. 398.350 Regulatory Actions Against Assemblers of X-ray Equipment that Fail to File Reports of Assembly (Status: Final)
- Guidance for Industry and Food and Drug Administration Staff - Assembler's Guide to Diagnostic X-Ray Equipment (Status: Final)
- CPG Sec. 398.600 Certification and Identification of X-ray Components - Sections 1010.2 and 1020.30(e) (Status: Final)
- Quality Control Practices for Compliance with the Federal Laser Performance Standard (Status: Final)
- Manufacture and Certification of Laser Kits (Laser Notice 13) (Status: Final)
- Procedures for Laboratory Testing of Microwave Ovens (Status: Final)