- FDA issued a new draft guidance Friday which seeks to clarify radiation control regulations for manufacturers of diagnostic X-ray systems and system components.
- The agency also said industry should be aware that CDRH plans to amend FDA’s performance standards to harmonize requirements with those of the International Electrotechnical Commission to simplify compliance for global manufacturers. Manufacturers are advised to regularly check the FDA website for new developments on this topic.
- The new draft guidance for industry on X-ray radiation controls will supersede FDA’s 1989 guidance on the subject when finalized.
Computed tomography (CT), fluoroscopy and radiography all use ionizing radiation to generate images of the body. Radiography is another term for conventional X-ray and includes mammography.
With ionizing radiation, high-energy wavelengths penetrate tissue to reveal the body's internal organs and structures. The body’s cells typically repair the damage from ionizing radiation, but damage to the DNA over time may increase a person’s lifetime risk of developing cancer.
According to Harvard Health Publishing, Americans’ total exposure to ionizing radiation has nearly doubled since 1980, which experts attribute to increased use of medical imaging, specifically CT scans.
Diagnostic X-ray systems are considered both medical devices and electronic products. The draft guidance covers requirements that apply to diagnostic X-ray equipment under the Electronic Product Radiation Control provisions of the Federal Food, Drug and Cosmetic Act and does not address those that apply to X-ray equipment as medical devices.
FDA said under its performance standards, manufacturers of diagnostic X-ray equipment must:
- Certify that each component complies with the applicable performance standards.
- Permanently affix certification and identification labels on the component or system that include name and address of the manufacturer, date and place of manufacture, model designation and serial number of each component.
- Provide the assembler with adequate instructions for assembly, installation, adjustment and testing of components.
- Provide the purchaser with adequate instructions describing technical specifications for the equipment, any radiological safety precautions and procedures necessary due to unique features of the equipment, and a maintenance schedule to keep the equipment in compliance with performance standards.
Additional information on requirements for assemblers of X-ray systems can be found in a separate guidance document.
Comments and suggestions on the document can be submitted within 60 days of publication of the notice of availability in the Federal Register. Electronic comments can be submitted to https://www.regulations.gov/.