USA – FDA Finalizes Two Guidances to Align X-Ray Imaging Devices With International Standards

The US Food and Drug Administration (FDA) on Tuesday finalized two guidance documents related to harmonizing X-ray device performance standards with international standards, and federal performance standards for fluoroscopic equipment.

On the harmonization front, FDA is looking to align performance standards prescribed by the Electronic Product Radiation Control (EPRC) with standards from the International Electrotechnical Commission (IEC) to help to ensure more efficient and consistent regulatory review of submissions for X-ray imaging equipment.

“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,” the agency said. The 6-page guidance finalized a draft from August 2016.

But because a recently proposed rule would eliminate the reporting requirements for X-ray imaging devices, FDA determined that the proposed policy outlined in the draft guidance, which stated that X-ray imaging devices that conform to IEC standards would be considered to have met the EPRC reporting requirements, should be removed from the final version.

“This decision was made to avoid the confusion inherent in establishing an interim procedure that would shortly be superseded by the final rule,” FDA said. “However, as stated in section V. of the guidance, FDA believes that submission of a declaration of conformity to the appropriate standards, and model identification as required by 21 CFR 1002.10(a) and (b), in a product report, would be sufficient to meet the requirements of a product report under 21 CFR 1002.10, thus reducing duplication.”…