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Medical X-Ray Imaging Devices Conformance with IEC Standards: Guidance for Industry and Food and Drug Administration Staff

FinalCenter for Devices and Radiological Health02/21/2023
Design ControlsDesign History File

Description

This guidance describes FDA’s policy regarding the regulation of medical x-ray imaging equipment that is subject to the Federal Food, Drug & Cosmetic Act (FD&C Act) and FDA’s regulations that apply to medical devices and electronic products. In this guidance, FDA is seeking to harmonize performance standards prescribed pursuant to section 534 of Subchapter C (Electronic Product Radiation Control (EPRC)) of the FD&C Act with International Electrotechnical Commission (IEC) standards, where appropriate, to help to ensure more efficient and consistent regulatory review of submissions for these products. The guidance also provides recommendations to industry on how to comply with the applicable requirements. FDA has determined that industry conformance to certain IEC standards would provide, at a minimum, the same level of protection of the public health and safety from electronic radiation as certain EPRC regulatory standards.

Key Topics

Terms and concepts identified from this document

Scope & Applicability

Product Classes

7
Diagnostic x-ray systems

considered to be both medical devices and electronic products

Diagnostic x-ray equipment

Subgroup of devices covered by collateral standards

Interventional fluoroscopy systems

Specific type of equipment covered by IEC 60601-2-43

Medical X-Ray Imaging Devices

Subject of the guidance document regarding conformance with IEC standards.

Class I Device

Low risk medical devices

Class II Device

Devices subject to section 522 postmarket surveillance orders; devices subject to postmarket surveillance orders

Class III Device

Generally recommended for Enhanced Documentation; Regulatory classification mentioned for implantable sensors and HPV tests; Mentioned in the context of an in vitro nucleic acid test for CMV DNA.

Stakeholders

3
Manufacturer

Entity responsible for submitting NDINs

Assembler

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

Importer

Must comply with registration if meeting facility/responsible person definitions

Regulatory Context

Regulatory Activities

4
510(k) Clearance

Regulatory pathway for medical devices mentioned in the policy section.

Declaration of conformity

Manufacturers should submit a declaration of conformity to IEC 60601-2-65

510(k)

Premarket notification submission type

PMA

Premarket Approval Application

Document Types

2
Declaration of Conformity

Premarket submission contents include a Declaration of Conformity.; Document included in premarket submission; Example ASCA Declaration of Conformity (DOC) for Basic Safety

Radiation Safety Specification and Testing Comparison Document

Document enabling assemblers to test devices against IEC specs

Identified Hazards

Hazards

3
Electronic Radiation

Public health and safety concern addressed by EPRC standards.

Hazardous electronic product radiation

Public health risk from non-compliant products

Radiation exposure

Hazardous and unnecessary exposure from electronic products

Standards & References

External Standards

10
IEC Standards

International Electrotechnical Commission standards for medical x-ray imaging devices

IEC 60601-2-65

Particular standard for Intra-Oral Dental Equipment

IEC 60601-2-63

Particular standard for Extra-Oral Dental Equipment

IEC 60601-2-45

Particular standard for Mammography

IEC 60601-2-28

Particular standard for X-Ray Tube

IEC 60601-2-43

Particular standard for interventional fluoroscopy systems

IEC 60601-1

Medical electrical equipment safety standard; Standard referencing subclauses 4.2.3.2 and 4.5 regarding modifications to test methods.

IEC 60601-1-3

Radiation protection in diagnostic X-ray equipment; Collateral standard for radiation protection in diagnostic x-ray equipment

IEC 60601-2-44

Particular requirements for CT equipment; Particular standard for Computed Tomography

IEC 60601-2-54

Particular requirements for radiography and radioscopy; Particular standard for radiography and radioscopy

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Related CFR Sections (14)

Enforcement Impact

Deficiencies cited in Warning Letters referencing the same regulations

Failure to establish and maintain procedures to control the design of the device
7
Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints
6
Failure to establish and maintain adequate procedures to control the design of the device
5
Failure to develop, maintain, and implement written Medical Device Reporting (MDR) procedures
5
Misbranded under section 502(o)
4
Adulterated under section 501(f)(1)(B)
4
Failure to establish and maintain procedures for implementing corrective and preventive actions
4
Failure to identify by suitable means the acceptance status of product
3
Failure to establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints
3
Failure to establish and maintain procedures for implementing corrective and preventive action
3

Recent Cases

Related Warning Letters (10)

Related MFDS Guidelines

Korean regulatory guidelines covering similar topics

See Also (8)