Guidance Seeks to Harmonize IEC, FDA Standards for X-Ray Devices

The FDA is attempting to harmonize performance standards with International Electrotechnical Commission standards for certain X-ray imaging devices.

The agency hopes to streamline the review process by providing recommendations on how devicemakers may meet FDA standards by conforming to IEC standards.

The agency said in draft guidance released Aug. 3 that it believes conformance to certain IEC standards would provide the same level of or improved protection from electronic radiation as Electronic Product Radiation Control (EPRC) regulatory standards.

Conformance to IEC standards would also be sufficient to meet 510(k) requirements for certain devices.

Industry had expressed concern about overlapping requirements for submissions to the FDA and EPRC for products that are both devices and electronic products. The agency addressed this overlap with previous guidance on ultrasound devices, laser products and computed tomography dose index devices.

The newly released guidance addresses diagnostic X-ray imaging systems and their major components. These devices are generally classified as Class I or II devices.

The guidance lists specific products for which conformance to IEC standards would be sufficient to meet 510(k) premarket notification requirements. Those devices include diagnostic X-ray beam limiting devices, spot-film devices and radiographic film and cassette changers.

Although a declaration of conformity to recognized standards could suffice to sidestep 510(k) submissions, the FDA would still need to review the test data addressed by the standards.

Device manufacturers would submit a declaration of conformity that is based on a GMP compliant testing program, the FDA said, and the manufacturer’s quality system should address radiation safety and conformity to standards through design controls. Testing results should be documented and placed in the firm’s records.

The agency said the policy described in the draft guidance would not apply if the FDA “finds that a manufacturer’s testing program does not assure the adequacy of safeguards against hazardous electronic product radiation or that it does not assure that electronic parts comply with the appropriate standards.”

By declaring conformance with IEC standards, devicemakers are asserting that they have established design specifications that relate to radiation emission, the guidance said. The guidance does not change the FDA’s policy toward enforcing correction of defects, the guidance said.

Earlier this year, the FDA issued final guidance on Applying Human Factors and Usability Engineering to Medical Devices, shedding light on the factors that companies should consider when developing devices to eliminate or reduce design-related problems that contribute to or cause unsafe or ineffective use.

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