FDA issues final guidance for medical X-ray imaging devices, fluoroscopic equipment requirements

The FDA issued a final guidance for medical X-ray imaging devices and a policy clarification for certain fluoroscopic equipment requirements.

In the final guidance for medical X-ray imaging equipment, the FDA looked to combine performance standards in section 534 of Subchapter C, Electronic Product Radiation Control (EPRC) of the Federal Food, Drug & Cosmetic Act with standards from the International Electrotechnical Commission(IEC) so the regulatory revision of submissions for these products is efficient. FDA also offered recommendations to the industry on how to follow applicable requirements. The guidance noted manufacturers and importers of medical X-ray devices are required to follow the current EPRC regulations and procedures or they must provide a declaration of conformity to IEC standards to fulfill EPRC regulation requirements.

In the final guidance for fluoroscopic equipment, the FDA sought to clarify the its interpretation of aspects of performance standard requirements in 21 CFR 1020.30 and 1020.32 for fluoroscopic equipment which include fluoroscopic irradiation time, last-image-hold images and emergency fluoroscopy mode.

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