Description
This publicationincludes all current FDA Compliance Policy Guides pertaining to the Performance Standard, interpretations of the Performance Standard in either narrative or question-and-answer form, and interpretive letters that have been sent to the industry. Manufacturers are reminded that they must also meet pertinent requirements of the Medical Device Amendments, which are not addressed in this document.
Scope & Applicability
Product Classes
7Guidance 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
A removable device which supports and may restrain a patient above an x-ray table.
Defined as a device with patient support structure interposed between patient and image receptor.
Additional recommended information for Electronic Product notifications
Guide for Preparing Initial Reports and Model Change Reports on Sunlamps
Warning label requirements; Products subject to performance standards and warning labels.
Field limitation and alignment requirements
Stakeholders
5Janet Woodcock, M.D. and Kathryn Zoon, Ph.D.
Entity 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
Installers of diagnostic X-ray systems; Entities installing X-ray equipment.
Accidental Radiation Occurrences and Foreign Manufacturers
Regulatory Context
Attributes
3Specific topic of importance for diagnostic x-ray equipment.; Required on identification labels in Month and Year format.; Determines which performance standards are applicable; required on identification labels
Maximum permitted levels for tabletops (1.0 mm to 2.0 mm Al).
Numerical indication requirement (SID)
Identified Hazards
Hazards
5Control unnecessary human exposure to potentially hazardous ionizing and nonionizing radiation
Radiation emitted by electronic products that requires control
A safety concern that must be tested for during assembly.
Control unnecessary human exposure to potentially hazardous ionizing and nonionizing radiation
Events requiring notification to the FDA
Related CFR Sections (7)
- 21CFR1020.30§ 1020.30 Diagnostic x-ray systems and their major components.
(a) Applicability.Read full regulation →
- 21CFR1000.3§ 1000.3 Definitions.
As used in this subchapter J:Read full regulation →
- 21CFR1003.2§ 1003.2 Defect in an electronic product.
For the purpose of this part, an electronic product shall be considered to have a defect which relates to the safety of use by reason of the emission of electronic product radiation if:Read full regulation →
- 21CFR1004.6§ 1004.6 Approval of plans.
If, after review of any plan submitted pursuant to this subchapter, the Secretary determines that the action to be taken by the manufacturer will expeditiously and effectively fulfill the manufacturer's obligation under § 1004.1 in a manner designed to encourage the public to respond to the proposalRead full regulation →
- 21CFR1003.11§ 1003.11 Determination by Secretary that product fails to comply or has a defect.
(a) If, the Secretary, through testing, inspection, research, or examination of reports or other data, determines that any electronic product does not comply with an applicable Federal standard issued pursuant to the Act or has a defect, he shall immediately notify the manufacturer of the product inRead 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 →
See Also (8)
- Manufacture and Certification of Laser Kits (Laser Notice 13) (Status: Final)
- Clarification of Radiation Control Regulations for Diagnostic X-Ray Equipment (Part 2) (Status: Final)
- Procedures for Field Testing Microwave Ovens (Status: Final)
- Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Compliance Policy Guides Index (Status: Final)
- Compliance Guide for Cabinet X-Ray Systems (Status: Final)
- Postmarket Management of Cybersecurity in Medical Devices: 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)