Description
FDA is issuing this guidance to provide clarification to industry and FDA staff of the Federal regulations that relate to diagnostic x-ray equipment. The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines diagnostic x-ray systems as both a medical device and an electronic product, therefore these systems are subject to the provisions of the FD&C Act that apply to both medical devices and to electronic products, and their implementing regulations. This guidance document only addresses the requirements that apply to diagnostic x-ray equipment under the electronic product provisions of the FD&C Act and the regulations implementing those provisions. These regulations pertain to the recordkeeping, reporting, manufacturing, importing, and installation of electronic products. It does not address requirements that may apply to diagnostic x-ray equipment as medical devices. This guidance supersedes FDA's guidance entitled “Clarification of Radiation Control Regulations for Diagnostic X-Ray Equipment” (HHS Publication FDA 89-8221 issued in March 1989).
Key Topics
Terms and concepts identified from this document
Scope & Applicability
Product Classes
10Guidance 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
special purpose x-ray system
special purpose x-ray system
special purpose x-ray system
designed for use with intraoral image receptors
Laminographic view equipment using a rotating source
Systems requiring LIH and air kerma displays
Example of device where tube failure is a serious safety issue
Devices subject to CT performance standards under 21 CFR 1020.33
considered to be both medical devices and electronic products
Stakeholders
4Entity responsible for submitting NDINs
Must comply with registration if meeting facility/responsible person definitions
responsibilities provided in FDA's guidance regarding installation; Personnel who install equipment and must follow manufacturer instructions.; Reports installation of diagnostic x-ray systems; Defined as any person engaged in the business of assembling, replacing, or installing components into a diagnostic x-ray system.; Person who installs, adjusts, and tests equipment
Entity responsible for designing systems to guarantee compliance; entity that certifies compliance with performance standards
Regulatory Context
Regulatory Activities
4Process for submitting suggestions to docket FDA-2018-D-4115.
Premarket notification submission type
manufacturer must furnish certification that product conforms to all applicable standards
A medical device submission type (IDE).
Document Types
5must include the name and address of the manufacturer, the place and month and year of manufacture; Label containing manufacturer and model info
Instructions provided to verify component labels and ensure compliance during installation.
Required safety statement on x-ray controls
Label denoting compliance with performance standards
Required documentation to keep equipment in compliance
Attributes
10Specific 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
must be equal to or greater than 160 lux
Required display feature for fluoroscopic equipment
Measurement required to be displayed in fluoroscopy
Electrical parameter that must be specified by the manufacturer for compliant operation.
The date the x-ray system is released to the facility for use on humans.
Peak tube potential, tube current, etc.
Requirement for label placement
Maximum requirements for front panels of cassette holders
identification label must include the model number and serial number
Technical Details
Testing Methods
2Tests performed after installation to ensure the system meets performance standards.
performed to confirm compatibility and compliance
Identified Hazards
Hazards
3Safety concern addressed in the guidance.; Reportable event involving unintended radiation emission
radiation hazard limited by performance standards
Radiation emanating from the diagnostic source assembly except for the useful beam
Standards & References
External Standards
4Graphical symbols for use on equipment
Standard for x-ray-based image-guided radiotherapy equipment
Standards referenced in the document for compliance
International Electrotechnical Commission standards for medical x-ray imaging devices
Specifications
7More stringent than regulatory limits to assure equipment meets standards
alignment and indication tolerance
minimum light intensity at 100 cm
minimum HVL requirements for beam quality
Design specification for x-ray tubes
Prescribed parameters for radiation emission
Regulatory requirements for the output and safety of x-ray equipment.
Related CFR Sections (17)
- 21CFR1002.1§ 1002.1 Applicability.
The provisions of this part are applicable as follows:Read full regulation →
- 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 →
- 21CFR1004.1§ 1004.1 Manufacturer's obligation to repair, replace, or refund cost of electronic products.
(a) If any electronic product fails to comply with an applicable Federal standard or has a defect and the notification specified in § 1003.10(b) of this chapter is required to be furnished, the manufacturer of such product shall;Read 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 →
- 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 →
- 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 →
- 21CFR1002.30§ 1002.30 Records to be maintained by manufacturers.
(a) Manufacturers of products listed under table 1 of § 1002.1 shall establish and maintain the following records with respect to such products:Read full regulation →
- 21CFR1003.10§ 1003.10 Discovery of defect or failure of compliance by manufacturer; notice requirements.
Any manufacturer who discovers that any electronic product produced, assembled, or imported by him, which product has left its place of manufacture, has a defect or fails to comply with an applicable Federal standard shall:Read full regulation →
- 21CFR1003.20§ 1003.20 Notification by the manufacturer to the Secretary.
The notification to the Secretary required by § 1003.10(a) shall be confirmed in writing and, in addition to other relevant information which the Secretary may require, shall include the following:Read full regulation →
- 21CFR1010.13§ 1010.13 Special test procedures.
The Director, Center for Devices and Radiological Health, may, on the basis of a written application by a manufacturer, authorize test programs other than those set forth in the standards under this subchapter for an electronic product if he determines that such products are not susceptible to satisRead full regulation →
- 21CFR801.1§ 801.1 Medical devices; name and place of business of manufacturer, packer or distributor.
(a) The label of a device in package form shall specify conspicuously the name and place of business of the manufacturer, packer, or distributor.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 →
- 21CFR1000.3§ 1000.3 Definitions.
As used in this subchapter J:Read full regulation →
- 21CFR1020.33§ 1020.33 Computed tomography (CT) equipment.
(a) Applicability.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 →
Enforcement Impact
Deficiencies cited in Warning Letters referencing the same regulations
Recent Cases
- 2026-02-24
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA)
ExThera Medical Corporation
- 2025-05-27
CGMP/QSR/Medical Devices/Adulterated
Sedecal S.A.
- 2025-05-20
Bioresearch Monitoring Program/Institutional Review Board (IRB)
United Health Products, Inc.
- 2024-11-08
CGMP/QSR/Medical Devices/Adulterated
Micro-X Ltd.
- 2024-07-16
Bioresearch Monitoring Program/IRB
Massachusetts Institute of Technology MIT
Related Warning Letters (9)
- 2026-02-24
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA)
ExThera Medical Corporation
- 2025-05-27
CGMP/QSR/Medical Devices/Adulterated
Sedecal S.A.
- 2025-05-20
Bioresearch Monitoring Program/Institutional Review Board (IRB)
United Health Products, Inc.
- 2024-11-08
CGMP/QSR/Medical Devices/Adulterated
Micro-X Ltd.
- 2024-07-16
Bioresearch Monitoring Program/IRB
Massachusetts Institute of Technology MIT
- 2024-03-12
Investigational Review Board (IRB)
Nobles Medical Technology II, Inc.
- 2023-11-14
CGMP/QSR/Medical Devices/Misbranded
Wello Inc.
- 2023-04-04
CGMP/QSR/Medical Devices/Adulterated
Synovo Production, Inc.
- 2020-04-07
Investigational Device Exemptions (Clinical Investigator)
Kennedy, Philip R.
Related MFDS Guidelines
Korean regulatory guidelines covering similar topics
See Also (8)
- Compliance Guide for Laser Products (FDA 86-8260) (Status: Final)
- Compliance Guide for Cabinet X-Ray Systems (Status: Final)
- Compliance Policy Guides Index (Status: Final)
- Laser Products - Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 (Laser Notice No. 56): Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Clarification of Radiation Control Regulations for Diagnostic X-Ray Equipment (Part 2) (Status: Final)
- Clarification of Radiation Control Regulations for Diagnostic X-Ray Equipment (Part 3) (Status: Final)
- Clarification of Radiation Control Regulations for Diagnostic X-Ray Equipment (Part 1 ) (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)